EMA has updated the guidance for applicants interested in gaining eligibility to the programme. New features include a roadmap to monitor development progresses of products, the possibility for SMEs and academic sponsors to seek early scientific advice, and submission readiness meetings to assess the availability of planned data and activities few months prior to the submission of the application for marketing authorisation.
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In parallel to the pharmaceutical legislation, also the European framework on intellectual property shall undergo an extensive upgrade. The Commission proposal includes regulations on Supplementary Protection Certificates for medicinal products and plant protection products, a regulation on compulsory licensing during emergency situations, and a regulation of Standard Essential Patents.
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Next EIPG webinar is to be held on 31st of May 2023 in conjunction with PIER and University College Cork, on the role and the procedures of Pharmacovigilance Risk Assessment Committee as a European body responsible for providing recommendations to EMA on any questions relating to pharmacovigilance activities in respect of medicinal products for human use.
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The package of reform proposed by the EU Commission consists of a Directive, a Regulation and a Council Recommendation on AMR. It completely redesigns the regulatory framework governing medicines’ development and authorisation. Incentive regime should be also renewed, but many criticisms already come from industrial associations commenting the proposal.
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The UK government has announced the Pioneer plan to be activated in the case of failure of the the negotiation with the EU Commission on the participation to Horizon Europe. The four key areas identified to support research and innovation are focused on attraction of talents, innovation, global collaboration and infrastructures.
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A report from Connect in Pharma identifies digitalisation of manufacturing and packaging processes, new drug delivery technologies for the administration of biological treatments, and connected devices among the major drivers supporting the transformative moment experienced also by the global pharmaceutical sector.
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An Aide-Memoire to support inspectors training and planning of activities and a Q&As list referred to PIC/S GDP Guide are the new guidance documents prepared by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Expert Circle on GDP
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The implementation of the new CEP 2.0 framework by the EDQM started with the mandatory inclusion of ORG_ID and LOC_ID data in applications. The revision of the design and pathway for the issuing of Certificates of suitability impacts on many other aspects of the process, which will be progressively implemented
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Equipment installed in pharmaceutical manufacturing facilities has to comply to GMP requirements. A new guidance document published by the ECA Foundation offers a detailed insight on all different items that should be considered in equipment design in order to achieve a successful validation and qualification
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Next EIPG webinar is to be held on Tuesday 18th April 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Graham Cook, former Pfizer’s Quality Intelligence and Compliance Information team leader and chair of EFPIA’s Manufacturing and Quality Expert Group (MQEG) will explain the context for the development of the ICH Q12 guideline on Product Lifecycle Management.
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The draft ICH M13A guideline is the first of a series aimed to address all the different elements part of the bioequivalence determination for immediate-release solid oral dosage forms. The public consultation is open until 26 May 2023.
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UK Prime Minister Rishi Sunak and the European Commission President Ursula von der Leyen announced that agreement had been reached on changes to the operation of the Protocol on Ireland/Northern Ireland.
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The two reports analyse the factors that may influence availability of antibiotics in the European market, identify 30 different classes of substances potentially at risk and propose an articulate set of possible solutions to address the issue of shortages under different perspectives
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The two regulators run the analysis of the exposure methods currently in use, according to the mandate received in 2020 by the EU Commission. The report set forth high-level recommendations on how to better approach the harmonisation of the exposure assessment; further discussion shall be necessary to better detail the needed interventions at the level of different sectional legislative frameworks
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Recent months have seen many proposals arising from the different industrial associations representative of the research-based industry (EFPIA), the generic, biosimilar and value added medicines sector (Medicines for Europe) and the ATMP sector (Alliance for Regenerative Medicine). The shared target is to contribute to the debate in view of the finalisation of the review of the European pharmaceutical legislation by the EU Commission
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A new elaboration process for CEP documents is going to be implemented by the EDQM, with inclusion of a new consultation phase for both public and restricted documents. The new process is described by a guidance document available at the EDQM’s website
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“Green” is the new inspirational word encompassing the development of new materials, methods and processes in the pharmaceutical field. The concept of environmental sustainability greatly evolved from the ’90-ies, and is now focused mainly on efficiency and carbon footprint to achieve the zero emission goals. The topic has been also addressed in a recent EIPG’s webinar held by Lif’s representative Dr Bengt Mattson
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In its December 2022, the European Council adopted its Conclusions on the European Innovation Agenda and Research Infrastructure. The documents shall now inspire the work of the European Commission to shape the final design of initiatives fundamental to sustain EU’s competitiveness and innovation, such as the European Research Area and Horizon Europe programmes
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The QIG group will assess emerging technologies in the field of development, manufacturing and quality control of chemical and biological medicines, and ATMPs. It could contribute to the issuing of recommendations and drafting or reviewing of EMA’s guidance documents. Its eight members shall participate to international regulatory initiatives and fora. Dedicated platforms shall be created to dialogue with external stakeholders
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The nine case studies elaborated by the international regulators members of ICMRA address the issue of antimicrobial resistance under different perspectives. The resulting comprehensive framework may support actions at both regulatory and governmental level to improve new actions to ensure a better use of antibiotics and a lower environmental impact
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The current date for the entry into force of the Unitary Patent Court Agreement is 1 April 2023. The Court has already appointed 85 judges, both legal and technical, and is running all the needed activities to validate the Case Management System. There are opportunities and risks for the pharmaceutical sector linked to the possibility to obtain a single property right valid in seventeen European countries, but the real impact of the new unitary patent system would be better evaluated only after the judges will provide their first decisions
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EMA released two overview documents listing all comments received during the public consultation on the draft guidelines ICH Q2(R2) and ICH Q14. Comments will be now evaluated by the ICH Q2(R2)/ICH Q14 Expert Working Group (EWG)
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This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S)
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A report by Iqvia discusses the issues impacting of the entry of competitors on the generic or biosimilar market, once all form of intellectual property protection expired. The topic is central to the ongoing revision of both the European pharmaceutical and intellectual property legislations
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A Warning Letter issued by the FDA highlighted issues connected to manufacturing of different types of products in shared equipment, which is considered a violation of the cGMP. In the EU, the current pharmaceutical legislation does not openly address the issue, giving more emphasis to the application of Quality Risk Management as the preferred tool to design and validate process, including cleaning validation. WHO’s guidelines contains some more details on some aspects of the problem
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At the next EIPG webinar to be held on Wednesday 9th November at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork, Bengt Mattson will present the impact of pharmaceuticals on the environment and what industrial pharmacists can do to help decrease the potential environmental impact.
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The EU has signed or is negotiating a wide range of trade agreements with countries in other geographic areas to reinforce it competitiveness in the global markets. UK and India are also discussing a new free trade agreement. In July 2022, the WTO approved a TRIPS waiver for Covid-19 vaccines, and discussions are ongoing to possibly extend it also to Covid treatments and diagnostics.EFPIA published a factsheet to support with data its negative opinion towards this possibility
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The still insufficient capacity of notified bodies may cause delays in the certification of new medical devices and in vitro diagnostics and in the re-certification of the already marketed ones. This may result in a supply crisis in case such activities would not be completed by the end of the transition period to the new MDR and IVDR regulations. A position paper by the Medical Devices Coordination Group discusses the possible solution immediately available to increase NB’s capacity
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A document published by BioPhorum discusses a four steps approach to the selection and validation of suppliers of raw materials. This process often proves critical to establish product lifecycle materials requirements from the very early clinical phase of development. The impact of incorrect forecasts may be high in terms of costs and possible delays of production along the entire lifecycle of the new product
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The newly published CIOMS report discusses the best practices that may be implemented along the entire lifecycle of a medicine, medical device, diagnostic or combination product in order to capture and consider the patient’s point of view from the very early phase of development down to regulatory processing, and post-marketing monitoring. Case studies are also provided to better explain the possible approach to different activities, including for example formulation development and regulatory public hearings
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A ICRMA’s joint statement and the new Big Data Workplan 2022-2025 jointly issued by EMA and HMA pave the way to the implementation of the use of big data analysis for regulatory decisionmaking. Some still open issues shall be address by discussion among the stakeholders, according to the detail timeline proposed in the workplan
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The Workplan 2022-2026 published by the European Commission, EMA and the HTA highlights the actions identified to pursued the ten priorities identified by ACT EU and provide a brief description of key deliverables and their associated timeline
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The Annual Report of the Federation of the European Pharmaceutical Industry Associations indicates the sector is still in good health, but suffers from the competition of more attractive economies. The length of the R&D process to reach the market together with regulatory barriers and the fragmentation typical of the European countries are still issues to be solved
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The 2021 Global Drug Delivery & Formulation Report highlights the recent trends in approvals of new drug formulations and drug delivery technologies. Injectable and oral products maintain the leading positions, but new approaches are emerging, for the example in the case of nasal delivery to treat ocular conditions
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The five areas of intervention of the new European Innovation Agenda announced by the EU Commission include investments to support startups and scaleups, development of regulatory sandboxes, initiatives to attract talents and to standardise the terminology used to draft policies and the creation of a network of regional innovation valleys
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Collaborative assessments of CMC and post-approval change submissions and hybrid inspections are the focus of the two one-year pilot projects launched by ICRMA in order to better harmonise procedures and expectations at the global level. A greater flexibility of regulatory procedures across different regions based on sharing of best practices and standards, collaborative inspections and alignment of procedures are among the main expected outcomes
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The ISG will act a specific reference point to support the dialogue of EMA with the industrial counterparts, under the new extended mandate. The three key areas of interest during the pilot phase are the Emergency Task Force, the shortages of critical medicines and medical devices and the experts groups on medical devices.
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Domestic inspections represented in 2021 the majority of inspective activities, according to EFPIA’s Annual Regulatory GMP/GDP Inspection Survey. Mixed tools are playing an increasing role, even if the learning phase of implementation is still ongoing. Collaboration, reliance and delegation are among the suggestions to improve inspection practices in the future. In the UK, the MHRA launched a pilot programme focused on the new figure of Compliance Monitor consultants for the supervision of activities pharmaceutical companies have to implement on the basis of the Compliance Protocol agreed with the regulator following an inspection.
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While delays are still experienced with the signature of contracts and the availability of funding for companies entitled to access the EIC Accelerator programme, the EU Parliament launched an investigation on the current governance of the EIC. The EIC Pilot Expert Group has proposed to create two dedicated deep-training programmes to better support the development of entrepreneurial skills.
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The DGA will regulate the sharing and reuse of public-sector data. It describes the rules applying to data intermediation services, digital platforms for the sharing of data and data altruism. EMA has published a draft guideline on how to approach the protection of personal data within CTIS. A public consultation on the document is open.
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EMA has published an updated timeline for the implementation of the new Digital Application Dataset Integration (DADI) user interface. The availability of the first web-form is expected in October 2022. The DADI project aims to improve interoperability of data and compliance to ISO IDMP standards for the identification of medicinal products, and to reduce the administrative burden for both the regulators and the industry
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The IVD regulation (EU) 2017/746 entered into force on 26 May 2022. The Medical Devices Coordination Group issued some new guidelines to clarify its interface with the Clinical Trial regulation and the implementation of the Unique Device Identification system. The BioMed Alliance In Vitro Diagnostics Task Force published a paper to discuss the many still open challenges and issues, including the impact on in-house developed diagnostic tests and innovation.
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The public consultation of the Q&As’ draft guideline is open up to 13 June 2022. The document discusses how to address the routine remote certification and confirmation of batches, including requirements for the QPs and MIA holders
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The IHI initiative published the draft text of the first two calls, expected to be launched in June. Innovative technologies are central to both, with a particular attention to digital health technologies and the possible contribution to prevention, diagnosis and treatment arising from artificial intelligence. Neurodegenerative diseases, cancer and cardiovascular diseases are the main therapeutic areas tackled by the announced topics, together with Early Feasibility Studies
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The Brasilian regulatory authority ANVISA is the 54th member of PIC/S. China’s FDA is among the regulatory authorities that filed a pre-accession procedure. In 2021 many new guidances were issued, and others are undergoing the process of revision
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The Medical Devices Coordination Group updated the priorities of its Joint implementation and preparedness plan in view of the full entry into force of the IVDR regulation on 26 May 2022. Two distinct sets of actions are discussed in the document, those essential to ensure the presence of IVDs on the market and the high-priority ones to support the smoother transition to the new legislative framework governing in-vitro diagnostics
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The acquisition of a pharmaceutical product requires the careful assessment of regulatory, quality and manufacturing elements and documentation as a part of the due diligence process. An exercise that may become highly complex in the case of an entire facility or a multi-site acquisition.
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The work plan defines the priorities of action to prepare for the entry into force of the new regulation (EU) 2021/228 on Heath Technology Assessment, including the setting up of the methodological and operative framework needed to support joint scientific consultations
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The European Council and Parliament reached on 14 March 2022 an agreement on the draft International Procurement Instrument (IPI). The entry into force of the new regulation will follow formal adoption by the two European Institutions. The new tool is expected to favour the expansion of European companies in third countries’ public procurement markets, on the basis of a reciprocity of access
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New biotech medicines and advanced therapies often require the development of innovative formulations and dosage forms. Not only as injectables: oral solid dosage forms are more acceptable to patients, and may include smart elements to monitor compliance to treatment as well as physiological parameters. Patients’ preferences are also important to develop new formulations for the OTC market
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After the closure of the pilot phase, in November 2021, the EDQM confirmed the Real-Time Remote Inspections (RTEMIS) programme as its third pillar to run inspective activities relative to GMP compliance and CEP certificates for API suppliers. The Directorate also released updated application forms for CEPs, and will soon launch its completely re-designed website
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The Pharmaceutical Inspection Co-operation Scheme has updated its PIC/S GMP Guide. The revised Annex 13 reflects the new EU “Clinical Trials” regulation, while Annex 16 is completely new and addresses the certification and batch release processes which fall under the responsibility of the Authorised Persons
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Industrial pharmacy specialization students from University of Helsinki, Terhi Liukko and Anni Svala, are conducting academic research of remote audits. To increase the knowledge of remote audits and sharing best practices, we kindly ask you to participate to the survey
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Factory acceptance testing and Site acceptance testing are key components of the commissioning process, as they support regulatory compliance to GMP and the overall quality and safety of pharmaceutical productions. A brief excerpt of the main features that should enter the planning of FAT and SAT testing
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The partnership includes all stakeholders interested in the development and sustainability of the European industrial sector. After a first set of actions launched in the contest of the Horizon Europe work programme 2021-2022, and aimed to support the green and digital transformation and circular economy, a preliminary consultation and discussions are ongoing to define the topics to be included in the new HE work programme 2023-2024
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Provisions applying to the import in the EU/EEA of human and veterinary medicinal products and investigational medicinal products are specified in Annex 21, that will enter into force on 21 August 2022. The document details the responsibilities of the importation site responsible for QP certification/confirmation of imported batches, including those referred to the Pharmaceutical Quality System and available documentation
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The European Commission published the Summary Report and attached documentation received during the public consultation on the revision of the pharmaceutical legislation. We summarise the main contributions from pharmaceutical and allied associations
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Revision 5 of the CDMh document includes modification of terms for the lifting of Conditions B and D to the marketing authorisation. A Communication of the FDA specifies that formulation design strategies may represent a possible approach to limit the presence of nitrosamine impurities in the final medicinal product
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A recent report published by the UK’s BioIndustry Association (BIA) and Clarivate illustrates the trends of investment in the biotech sector in 2021. The country confirmed its high attractiveness for investors, both with regard to venture capitals and IPOs
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Early formulation studies pose many challenges, but represent a critical point to reduce the time-to-market needed to make available a new medicinal product to patients. Poor solubility of the active ingredient is often a main issue to be faced, together with the optimisation of its stability, bioavailability and manufacturability
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The strategic document “Accelerating Clinical Trials in the EU” released by the EU Commission, EMA and HMA indicates six objectives and ten specific actions for years 2022-2023 to improve the European framework for clinical trials and the attractiveness of Europe to host larger, multinational studies
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The document issued by EMA and the HMA discusses the principles and recommendations identified as requirements to achieve the harmonised adoption, adaptation and implementation, by regulatory authorities members of the EMRN, of common standards to manage data for regulatory purposes
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The experience gathered by regulatory authorities at the international level during the pandemic was analysed by ICRMA’s working group to highlight critical issues and cases where this type of approach proved unfeasible. On-site inspections shall continue to be run also in future, suggests the regulators’ association. GMP and GCP inspections are discussed in detail in the document
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The guideline resumes the questions posed in October 2021 during a live webinar organised by EMA to support interested parties with the transition to the new system, that will become fully operative since 28 January 2022, together with the new Veterinary Medicinal Products Regulation
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This update of the guideline further clarifies specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and product-specific concerns in proposed (invented) names
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The study was commissioned in March 2020; it suggests 16 possible policy measures that the Commission may consider while drafting a new legislative proposal, expected to be announced at the end of 2022
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A new step in the compulsory use of Organisation Management Service (OMS) data has been implemented on November 1st, 2021. All organisations are required to verify and submit changes to their data, that will be validated by EMA before their use to submit applications for centrally authorised products. Further discussion is ongoing to extend the use of OMS data also to national procedures within the next couple of years
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The resolution approved by the European Parliament shall now be transmitted to the European Council. The document suggests how to improve the IP Action Plan presented in November 2020 by the Commission. Other suggestions came also from the industrial associations
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An important challenge in continuous integrated biomanufacturing is represented by the method used to define production batches. An article published in the J. Chem. Technol. Biotechnol. discusses the possible use of the great common divisor to take into consideration the time-dependency and periodic behaviour of semi-continuous processes in order to achieve the optimal definition of the batch size
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After the adoption by the Council of Europe, the HTA regulation should be also endorsed by the EU Parliament; it will come into force three years after publication in the EU Official Journal. To support the implementation phase, the new Heads of Agencies Group has been created; EUnetHTA 21 consortium has signed a Service Contract with HaDEA, and launched the first Open Call targeted to the pharmaceutical industry
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Antiviral monoclonal antibodies, oral antivirals and immunomodulators are the three categories of therapeutics the expert group identified as the most promising with respect to the rapid development and approval of new options for the treatment of the infection. The selected candidates may now access EMA’s scientific advice, regulatory flexibility pathways and HERA’s innovation support tools in order to undergo formal regulatory assessment and approval
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The draft agreement reached by the Council of the EU and the European Parliament enlarges EMA’s action to the management of crisis preparedness, with a special focus on the availability of medicines and medical devices needed to face health emergencies. A pilot project was launched by the Agency to support the repurposing of off-patent medicines; research activities shall be run by not-for-profit organisations and the academia, while the pharmaceutical industry shall be responsible for the submission of requests of authorisation for the new indications
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The formal ratification of the Treaty by Cameroon has started the count down towards the operative phase of implementation of AMA by the African Union. The newly born Agency will be responsible for the promotion and coordination of regulatory activities among the adhering countries, with the aim to reach a better harmonisation of the framework for medicines’ development, manufacturing and approval in Africa.
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The presence of robots within closed isolators allows for the almost complete elimination of human operators from cleanrooms, thus reducing the risk of contamination. The available technologies are now highly standardised, and offer many opportunities for new designs of the manufacturing process, especially in the field of advanced therapies.
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Three different calls for tender on antimicrobial resistance and strategic stockpiling of therapeutics to treat Covid-19 are the first activities launched by the EU Commission to provide the basis for the new European Health Emergency preparedness and Response Authority to become fully operative. Several stakeholders commented HERA’s objectives and possible approaches to the operative phase.
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The initiative launched by the European Commission is open for comments until 21 December 2021. As established by the EU’s Pharmaceutical Strategy, it aims to collect opinions from all the different stakeholders as the first step towards the review of the current pharmaceutical legislation to better reflect the state-of-the-art in technology, innovation and regulatory sciences.
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The public consultation on the ICH Q13 guideline of continuous manufacturing of drug substances and drug products is open until 20 December 2021. The guideline provides the general framework for the development and operation of a CM system, both under the scientific and regulatory perspective. It also offers examples to illustrate the main features to be considered under the different domains of pharmaceutical manufacturing.
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The guideline published in July by EMA addresses integral, co-packaged and referenced medicinal products. It describes the quality information to be submitted to competent authorities as part of the authorisation dossier to prove compliance to requirements of the Medical Devices Regulation.
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The cultivation and manufacturing of cannabis-based medicinal products is rapidly expanding in many European countries. There is still lack of harmonised legislation governing the sector, many countries have developed internal laws to support investments in the field. In Germany the BfArM has started the state sell of domestic medical cannabis; Greece and Malta present favourable climatic locations for cultivation and have approved a specific regulatory framework.
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The proposal adopted by the EU Commission details the main features and approach to the realisation of the new European Research Area and calls member states to voluntary increase the level of R&I investments up to the 3% target planned for 2030.
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Non-commercial repurposing of oncology medicines may offer interesting opportunities for treatment of rare cancers, but many issues still have to be solved. The topic has been debated during the last Joint meeting of EU Directors for Pharmaceutical Policy & Pharmaceutical Committee.
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The launch of the new Life Science Vision by the UK’s government has corresponded to a successful moment in the raising of investments in the biotech sector and to the publication of the new Code of Practice for the promotional activities of prescription medicines.
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Over the last 20 years Physiologically–Based Pharmacokinetic(PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry.EIPG’s and PIER’s next webinar,to be held on 21st October 2021.
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The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published on 16 August 2021.
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ICH guideline Q13 on continuous manufacturing of drug substances and drug products.
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.
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The new strategy will be adopted by all Swiss university hospitals and academic institutions. It provides a common semantic framework to be used in synergy with the existing tools to meet the needs of both patients and the healthcare system.
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The guideline is intended to support the work of inspectors for the verification of good data management practices and data integrity related to GMP/GDP activities in pharmaceutical manufacturing. Its adoption is not mandatory, and the principles described can apply to all elements of the Pharmaceutical Quality System.
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Many activities are completely reshaping the European research landscape. The European Commission is negotiating with several third countries their participation to Horizon Europe’s projects. Many Science organisations have expressed their position about the current exclusion of Switzerland. Science Europe has published its new Strategy 2021-2026. Five industrial associations in the pharmaceutical and medtech sectors have published a Strategic Agenda for Research & Innovation in Healthcare to guide the new public-private partnerships planned under the proposed Innovative Health Initiative (IHI) framework.
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SSMs are useful to simulate many different processes typical of biomanufacturing, both in early and late development. A series of articles on BioProcess Online discusses how to approach the implementation and qualification of small-scale models under an industrial perspective.
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The European Medicines Agency (EMA) has published a new document entitled “Frequently asked questions about parallel distribution” (EMA/297155/2021). The 30-page PDF file contains answers to the most common questions. .
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The Post-COVID Era and Pharmacy
Luigi Martini, Chief Scientist at the Royal Pharmaceutical Society chaired an EIPG Symposium on the lessons learned from the pandemic and how pharmacists can shape the future in a post-COVID era.
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