From the Bureau Archives - Page 2 of 5 - European Industrial Pharmacists Group (EIPG)

Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS

by Giuliana Miglierini The Data Governance Act (DGA) was approved and adopted in May 2022 by the European Council, following the positive position of the EU Parliament; the new legislation will entry into force after being signed by the presidents Read more

The transition towards EMA's new Digital Application Dataset Integration (DADI) user interface

by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based electronic applications forms (eAFs) used for regulatory submissions with new web-forms accessible through the DADI user interface. The European Medicines Agency (EMA) has Read more

IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics

by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into force on 26 May 2022. The new rules define a completely renewed framework for the development, validation and use of these important Read more

The Practical Implementation of EU Regulations for Medical Devices and in vitro Diagnostic Medical Devices (Webinar)

In EIPG’s and PIER’s next webinar, John Deavin will review current Medical Device Directives and the timetable for transition to the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), the proposed UK system.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

Annex 1 – a focus on its main issues (Webinar)

EIPG and Tecniche Nuove’s next webinar, presented by Dr Francesco Bosci, summarizes the most relevant comments to the V12 draft document of Annex 1 (appendix of Eudralex Vol. 4 EU GMP) as developed by the EIPG national working groups and delivered to EC for consideration for the preparation of the final Annex to be published. Comments are mainly focused on the key issues about the aseptic process, such as premises, personnel, production technologies and process monitoring.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

How a pandemic has affected the pharma industry (Webinar)

In EIPG’s and PIER’s next webinar, Dr Sheuli Porkess will review the changes in the way research is being undertaken as a result of COVID with the current extraordinary collaboration between industry, academia, charities, foundations and public-private partnerships, and contemplate whether these changes are likely to continue in a highly competitive industry. She will discuss how to achieve robust research “at a pace” especially when vaccines for the elderly do not usually produce extensive immune response. She will explain the positive aspects of the management of clinical trials during COVID and whether there are likely to be permanent changes resulting from the experience with COVID. She will reflect on what we have learnt about the sudden switching to manufacture of medicinal products needed in Intensive Care Units and other supportive medicines for COVID patients. She will consider whether the established management systems set up to prevent shortages of medicines are working post-COVID or whether COVID-related medicines are causing shortages of other medicinal products.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

EIPG publishes updated version of Code of Practice for Qualified Persons

The EIPG Code of Practice for Qualified Persons has been conceived with the aim of offering an updated view of the legal and technical requirements pertaining to the position of the Qualified Person (QP) in Europe. The added value of this document is represented by the comments and recommendations which have been added to each requirement, taking into account the practical experience of many European industrial pharmacists in their role of QPs.

Authored by EIPG Vice-President Technical and Professional Development Piero Iamartino and EIPG Vice-President European Affairs Maurizio Battistini, with contributions by Luciano Gambini (Italy), and contributions from Italy, Belgium, Spain, UK and Czech Republic, the scope of this document to provide a living Code of Practice by ensuring a constant updating as a consequence of the introduction of new European requirements pertaining to the QP and considering the possible integration of new comments based on the contributions of EIPG members.

The EIPG Code of Practice for Qualified Persons 2020 is available on the EIPG Website in the EIPG Guides and Codes section.

Consultation on Annex 21: Importation of medicinal products, of the EudraLex Volume 4 (Webinar)

EIPG’s and PIER’s next webinar, presented by Stan O’Neill, will address the European Commission’s has targeted stakeholders’ consultation on the draft Annex 21: Importation of medicinal products, of the EudraLex Volume 4. This new Annex, in which the Qualified Person (QP) has a key role, and which has been under discussion for a long time, provides guidance for the interpretation of the principles and guidelines of GMP for both human and veterinary medicinal products. The document intends to bring clarity to areas which have been unclear for some time, and the speaker will discuss the background to the Annex, the challenges which have existed within the EU Regulatory Framework, and how the proposed Annex may or may not address these challenges. The speaker will suggest potential areas of concern, and how delegates may wish to communicate these to the European Commission both via the European Commission’s own communication process, and through the participation of their member organisations in the consultation process within the European Industrial Pharmacists Group.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

The role of the body clock in drug development, efficacy and toxicity (Webinar)

EIPG’s and PIER’s next webinar, presented by Dr Annie Curtis, will cover the role of the body clock in drug development, efficacy and toxicity. For centuries we have known that rhythms in our physiology exist so that our bodies stay in tune with the daily cycle, imposed by the rotation of the Earth. Twenty years ago scientists began to genetically pick apart the molecular make-up of these rhythms, and discovered that each of our cells has the capacity to tell the time of day. This has opened up a new field in biology, called chronobiology, which is the study of our body clocks in health and disease. Today, this field has begun to unpick the implications of our body clocks in terms of drug development, efficacy and toxicity. This has major implications as up to half of the 100 top selling medicines are against a target that is controlled by our molecular clock, leading to daily changes in the expression of this target. Chronotherapy has the aim of harnessing our body clocks and these subsequent rhythms to improve the efficacy and safety of drugs.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

Medicines shortages: root causes and potential solutions

Medicines shortages are a significant cause of concern for patients, clinicians and our public health. They impact on patients’ health outcomes by causing delays in treatment or forcing changes in treatment regimes as well as inducing a great deal of stress and worry to patients and their families.

The European associations representing manufacturers of vaccines and medicines, parallel distributors, pharmaceutical full-line wholesalers and industrial pharmacists are committed to working with the EU and member states to progress short term and longer term solutions addressing the root causes of medicines shortages that occur across Europe.

The root causes of medicines shortages include manufacturing, quality, economic, and supply chain issues. Our associations are committed to stepping up efforts to prevent and to mitigate medicines shortages. As a group, we believe that the root causes of shortages can be addressed by a set of short term and longer term solutions including harmonising data and monitoring medicines shortages at EU level, creating regulatory incentives for essential low-priced medicines, allowing regulatory flexibility and improved regulatory efficiency to mitigate shortages, and ensuring market stability and sustainability.

We call for a dialogue with EU and national competent authorities in order to implement solutions effectively addressing the root causes of shortages in the short, medium and long term perspectives rather than placing short term disproportionate requirements on manufacturers and supply chain stakeholders that could have opposite effects to the ones intended.


Notes to Editors

1. The joint paper on addressing the root causes of medicines shortages in full can be accessed here.

2. The joint paper has been developed and agreed by the following organisations:

• The Association of the European Self-Medication Industry (AESGP) is the official representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. AESGP was founded in 1964 to contribute to the improvement of responsible self-medication at the European level and to ensure that the value of responsible self-care is recognised in pharmaceutical, food and health matters.

• The European Association of Euro-Pharmaceutical Companies (EAEPC) represents Europe’s licensed parallel distribution industry, an integral part of the European pharmaceutical market that adds value to society by introducing price competition and a supplementary layer of safety for medicines. We represent 125 companies in 23 EU/EEA Member States. These members account for approximately 85% of the total parallel import market volume in the EU/EEA.

• The European Industrial Pharmacists Group (EIPG) is a European association representing the national, professional organizations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines.

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 36 national associations and 39 leading pharmaceutical companies, EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. Our vision is for a healthier future for Europe. A future based on prevention, innovation, access to new treatments and better outcomes for patients.

• The European Healthcare Distribution Association (GIRP) is the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 34 European countries, as well as major international and pan-European healthcare distribution companies. GIRP members employ over 140,000 people and distribute around 15 billion packs of medicines as well as a wide range of healthcare products per year. As the vital link in healthcare, they are committed to developing and providing innovative and efficient healthcare products and services to improve health and wellbeing of patients across Europe.

• Medicines for Europe (formerly EGA) represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.

• Vaccines Europe (VE), is a specialised vaccines group within the European Federation of Pharmaceutical Industries and Associations. Formed in 1991, Vaccines Europe represents major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe which account for a large share of human vaccines used worldwide. Companies represented within Vaccines Europe are involved in research and development (R&D), clinical trials, production and marketing of vaccines and are dedicated to improving public health through immunisation.

GMP documentation management: requirements and best practices (Webinar)

EIPG’s and PIER’s next webinar, presented by Alessandro Regola, will cover the GMP requirements and the practical implementation of a management system for quality related documentation. After an introduction referencing the relevant GMP norms and guidances, the different types of documents will be described with their function in the Quality System and their requirements. Paper and electronic based systems will be described with their peculiarities. The presentation will continue with a description of the most frequent deficiencies in documentation management, including some examples of Authorities’ observations during inspections (observations from FDA, EMA and MHRA inspections will be presented). Finally, some best practices will be presented, combining GMP compliance and efficiency in documentation management and recommended by the speaker based on his experience.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

EIPG notes risk of shortages of medicines in Europe arising from the Falsified Medicines Directive and Brexit

During the EIPG General Assembly held in Casablanca on 5 and 6th May, two Working Groups reviewed the implications for Qualified Persons of the Falsified Medicines Directive and the impact of Brexit on European industrial pharmacists in their roles to ensure availability and accessibility of quality, safe and efficacious medicinal products for patients.

The first Group considered the responsibilities of Qualified Persons involved in serialisation. The structure of a guidance document was discussed and it was recommended to issue the publication as soon as possible after this General Assembly, due to the impending deadlines and increased serialisation activities.

The second Group recommended that clarity is required for the Qualified Persons of pharmaceutical importers in terms of their roles and responsibilities in view of the technological challenges arising from serialisation which they will have to face. The Group noted that all actors in the pharmaceutical supply chain must adapt their quality systems in considerably short time frames and this relies heavily on key individuals, in particular Qualified Persons and Responsible Persons.

Commenting on the outcomes of the Working Groups, EIPG President Claude Farrugia noted that since the Falsified Medicines Directive deadline coincides with Brexit, this exacerbates the potential risk to the availability of medicines.

EIPG Feedback on Revised Annex 1

The European Commission recently launched a targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex Volume 4. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.

Read the EIPG Comments on the revised Annex 1.