Newsletter

Steps forward towards the new framework for HTA
26 November 2021 | Giuliana Miglierini

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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Commission establishes portfolio of 10 most promising treatments for Covid-19
19 November 2021 | Giuliana Miglierini

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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A new role for EMA and a pilot project for the repurposing of medicines
12 November 2021 | Giuliana Miglierini

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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A step forward towards the African Medicines Agency
5 November 2021 | Giuliana Miglierini

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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Automation of aseptic manufacturing
29 October 2021 | Giuliana Miglierini

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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First steps of the HERA Authority and comments from industrial and medical associations
22 October 2021 | Giuliana Miglierini

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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Consultation on the reform of the European pharmaceutical legislation
15 October 2021 | Giuliana Miglierini

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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Consultation open on the ICH Q13 guideline on continuous manufacturing
8 October 2021 | Giuliana Miglierini

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 new guideline on combination products between medicines and medical devices
1 October 2021 | Giuliana Miglierini

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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Medical Cannabis in Europe
24 September 2021 | Giuliana Miglierini

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 Pact for Research and Innovation in Europe
17 September 2021 | Giuliana Miglierini

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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The opportunity for repurposing of oncology medicines
10 September 2021 | Giuliana Miglierini

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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A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry
3 September 2021 | Giuliana Miglierini

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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Webinar: PBPK Modelling and Simulation
27 August 2021 | EIPG

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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Artificial intelligence in medicine regulation
20 August 2021 | Giorgos Panoutsopoulos

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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Draft guidelines, open for consultation
13 August 2021 | EIPG

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 Swiss interoperable national eHealth infrastructure
6 August 2021 | Giuliana Miglierini

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 new PIC/S guideline on data integrity
30 July 2021 | Giuliana Miglierini

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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The new vision for the European research landscape
23 July 2021 | Giuliana Miglierini

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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Small-scale models for process development
16 July 2021 | Giuliana Miglierini

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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EMA publishes Q&A document about Parallel Distribution
9 July 2021 | EIPG

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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EIPG Virtual Symposium
The Post-COVID Era and Pharmacy
2 July 2021 | Jane Nicholson

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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