The marketing authorisation and monitoring of the quality, efficacy and safety of medicinal products are administered on an international level by a European and a global network. Guidelines and laws on the structure of the medicinal product market are developed in close international cooperation. Experts from the Paul-Ehrlich-Institut are active in the working groups of the various international organisations that are of importance in this field.
- EMA (European Medicines Agency)
- Heads of agencies for human and veterinary medicine (HMAs)
- EDQM (European Directorate for the Quality of Medicines)
- EC (European Commission)
- WHO (World Health Organization)
- Bilateral international Co-operation
EMA (European Medicines Agency)
The EMA is an agency of the European Union responsible for the scientific assessment and supervision of medicinal products authorised in the centralised procedure. It was established on the basis of Regulation (EEC) No 2309/93 and is based in London.
Within the agency, various committees with different responsibilities have been founded. All EU member states, as well as its associated countries Iceland, Liechtenstein and Norway have a representative.
The Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) are the EMA’s highest scientific decision-making bodies. They are involved in the marketing authorisation and risk assessment of medicinal products for human and veterinary use. In the CHMP, the PEI is represented by a co-opted member elected due to his expertise in the field of advanced therapies. In the CVMP, the PEI is represented by a scientific colleague.
The Paediatric Committee (PDCO) deals with matters concerning the testing of medicinal products in children, such as Paediatric Investigation Plans (PIPs). The PEI provides the chair position.
In the Committee for Orphan Medicinal Products (COMP) which assesses applications from pharmaceutical companies for the classification of medicinal products as orphan medicinal products, i.e. medicinal products for the treatment of rare diseases, Germany is represented by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
Based on Regulation (EC) 1394/2007, another European body was established at the EMA in January 2009 – the Committee for Advanced Therapies (CAT). This committee is composed of renowned experts for the fields of gene therapy, somatic cell therapy, and biologically modified tissue products – so-called advanced therapy medicinal products (ATMP). It is completed by two representatives of patient organisations and two practicing doctors. The CAT is in charge of all procedures (marketing authorisations, certifications, and classifications) concerning ATMPs and, among other activities, prepares scientific recommendations on the marketing authorisation of advanced therapy medicinal products for the CHMP. The PEI provides the chair position.
The Pharmacovigilance Risk Assessment Committee (PRAC) was established in 2012. It is responsible for assessing and monitoring safety issues for human medicines anddeals with pre- and post-authorisation pharmacovigilance tasks and measures for human medicinal products lincensed in more than one member state oft he EU. Due to its specific expertise regarding the the safety of biological human medicines, the PEI is represented by a co-opted member.
CHMP and CVMP are supported by a large number of working parties composed of established experts from the national regulatory authorities. In conformity with their scientific specialisation, these working parties' task is to support the CHMP / CVMP in the assessment of application for new marketing authorisations for medicinal products, post-marketing procedures (variation notifications/renewals of the marketing authorisation). In addition, the experts contribute to preparing scientific guidelines and are, among other things, also involved in pre-authorisation scientific advice/protocol assistance.
The most important CHMP working parties with PEI involvement
Permanent working parties
For information on working programmes please refer to the appropriate link.
Temporary working parties
These working parties provide support with respect to temporary scientific issues and the preparation of scientific guidelines.
- Biosimilar Working Party (BMWP) (The PEI provides the chair position.)
- Biostatistics Working Party (BSWP)
- Blood Products Working Party (BPWP) (The PEI provides the chair position.)
- Vaccine Working Party (VWP)
- Oncology Working Party
- Pharmocogenomics Working Party (PGWP)
- Rheumatology/Immunology Working Party (The PEI provides the chair position.)
- Joint CVMP/CHMP Working Group on the application of the 3Rs (J3RsWg 3R)
The most important CVMP working parties with PEI involvement
- Immunologicals Working Party (IWP) (The PEI provides the chair position.)
- Pharmacovigilance Working Party – Veterinary (PhVWP-V)
- Scientifc Advice Working Party – Veterinary (SAWP-V)
The above committees (CHMP, CVMP) can also set up ad hoc working groups, which are tasked with investigating a particular scientific topic. PEI experts also collaborate in these groups, for example in the ad hoc Expert Group on Veterinary Novel Therapies (ADVENT).
In addition, there are so-called 'Scientific Advisory Groups' set up ad hoc for specific questions, generally in connection with a specific procedure to support the committees CHMP, CVMP, CAT, COMP, PDCO or PRAC in the assessment of specific product groups or forms of treatment. These are usually so-called external experts who are not staff members of national regulatory authorities but have special expertise in a particular area in their role as university professors or practicing doctors.
Heads of agencies for human and veterinary medicine (HMAs)
The heads of the national regulatory agencies of the extended European Economic Area (EEA) have formed an organisation called Heads of Medicines Agencies. They pursue the aim of harmonising their national activities, in particular in the context of marketing authorisations and authorisations of clinical trials through a European network. The president of the PEI is the chair of the HMA Management Group.
HMA are supported by the co-ordination groups below as well as by tasks forces and sub-groups working on specific temporary issues. While the HMA is involved in strategic questions, the focus of the work of the co-ordination groups for Mutual Recognition and Decentralised Procedure (CMD) is the clarification of questions in connection with the Mutual Recognition Procedure, national marketing authorisations, decentralised marketing authorisations, and post-marketing authorisation procedures (variations, renewals). This also concerns the implementation of European statutory regulations, the preparation of regulatory guidelines, and procedures in the case of divergent scientific views (referrals).
The task of the Clinical Trial Facilitation Group (CTFG) is to harmonise procedures and requirements for the authorisation of clinical trials within the scope of national responsibility.
The PEI is a member in the following working parties:
- Benchmarking Steering Group (BEMA) (The PEI provides the chair position.)
- Clinical Trial Facilitation Group (CTFG)
- CTS Working Group
- European Medicines Agencies Cooperation on Legal and Legislative Issues (EMACOLEX)
- EU Network Training Centre (EUNTC)
- HMA/EMA Task Force on Big Data
- Working Group of Communication Professionals (WGCP)
- Working Group of Quality Managers
Coordination Group for mutual recognition and decentralised procedures
The Coordination Groups for human and veterinary medicinal products were established in 2005 on the bases of Section 27 of Directive 2001/83/EC (human) and Section 31 of Directive 2001/82/EU (veterinary), respectively for the resolution of issues in the context of the decentralised EU procedures.
- Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh)
- Co-ordination Group for Mutual Recognition and Decentralised Procedures – veterinary (CMDv)
EDQM (European Directorate for the Quality of Medicines)
The EDQM is a directorate of the Council of Europe. The duties of the EDQM include maintaining and further developing the European Pharmacopoeia and co-ordinating the Official Medicines Control Laboratories (OMCL). These laboratories are involved in the batch testing and market surveillance of medicinal products for human and veterinary use authorised acc. to national, centralised and decentralised procedures. In this context, the EDQM coordinates the preparation of product specific guidelines on testing of medicinal products as well as overriding guidelines on quality management aspects and procedural issues of the official control authority batch release (OCABR) network. The compliance of the guidelines is ensured by the mutual recognition of testing and batch release within the OCABR networks and is monitored in mutual joint audits in the individual OMCLs.
Furthermore, the EDQM organises collaborative studies to assure the quality in the testing laboratories and on establishing new methods (such as alternatives for animal experiments). In addition, it co-ordinates the establishment of European biological reference products (standards) and takes charge of the storage and distribution of these products.
Staff from the Paul-Ehrlich-Institut participate in various EDQM working groups:
European Pharmacopoeia Expert Groups
- Group 1 (Biological Methods and Statistical Analysis)
- Group P4 (Biologicals)
- Group 6B (Human Blood and Blood Products)
- Group 15 (Sera and Vaccines)
- Group 15V (Veterinary Sera and Vaccines)
- Group 16 (Plastic containers for pharmaceutical use)
European Pharmacopoeia ad hoc Working Groups
- Allergens (The PEI provides the chair position.)
- Bacterial Endotoxin Test (The PEI provides the chair position.)
- Botunlinum Toxin
- Bovine Serum
- Cell Therapy Products
- Electronic batch submission
- Gene Therapy Products
- Glycan mapping
- Host Cell Proteins
- Live Biotherapeutic Products
- Monoclonal Antibodies
- P4 Bio Biologicals
- Raw Materials for the Production of Cellular and Gene Transfer Products
Technical Advisory Boards
- Certification of Suitability of Monographs of the European Pharmacopoeia, TSE (Transmissible Spongiform Encephalopathy) Risk Products
Establishment of standards, methods, testing guidelines, quality assurance
- Biological Standardisation Programme – Steering Committee
- Biological Standardisation Programme – Project Leaders
- Biological Standardisation Programme – Participants in Collaborative Studies
- Elaboration of Common European Quality Standard Regarding Quality Systems for Blood Establishment (TS066)
- Plasma Supply Management (TS093)
EDQM/OMCL network advisory groups
- Advisory Group OCABR: Batch release for human biologicals: Vaccines, blood and plasma derivatives
- Advisory Group VBRN: OCABR/OBPR for Immunological Veterinary Medicinal Products (IVMPs)
EC (European Commission)
The European Commission is the executive body of the European Union (EU). Its functions include both the development and implementation of pan-European pharmaceutical legislation and the supervision of European treaties and statutory regulations. Furthermore, the EC administrates the budget plan of the EU and is responsible for the assignment of financial aid. The EC is thus one of the most important bodies within the European Union whose interests it preserves and represents.
The European Commission is subdivided into various divisions, called Directorates General (GD). The Directorate General for Health and Consumers, DG SANCO is actively supported by the Paul-Ehrlich-Institut. Through their participation in various working parties, members of the institute contribute to the co-ordination and harmonisation of the marketing authorisation of medicinal products for human and veterinary use in Europe.
WHO (World Health Organization)
The World Health Organization (WHO) is the United Nations’ specialised agency for health issues, with more than 194 member states. WHO's objective is the attainment by all peoples of the highest possible level of health.
In order to achieve this objective, WHO has set up a large number of committees and working groups that, for example, draw up detailed requirements and guidelines. These are then published in the Technical Report Series (TRS) and may, for instance, define the procedures for the manufacture, marketing authorisation and control of blood products and vaccines. The members of these committees are supplied by various organisations including national marketing authorisation agencies.
WHO committees with regular PEI involvement
- Expert Committee on Biological Standardization (ECBS)
- Global Advisory Committee on Vaccine Safety (GACVS)
- International Nonproprietary Names Expert Group (INN)
- Product Development for Vaccines Advisory Committee
- Strategic Advisory Group of Experts for Vaccines and Immunization (SAGE)
International Conference of Drug Regulatory Authorities (ICDRA)
The International Conference of Drug Regulatory Authorities represents a WHO forum in which the representatives of the WHO member states discuss subjects of world-wide interest and advance global regulatory harmonisation. Joint aims are formulated as recommendations. The Paul-Ehrlich-Institut has been taking part in the ICDRA's conferences ever since 1999, among other things, by chairing some of the working parties
WHO Collaborating Centres
The Division Haematology and Transfusion Medicine is designated as WHO Collaborating Centre for the Quality Assurance of Blood Products and in vitro Diagnostic Devices (IVD). In this function it supports WHO with conferences held in connection with blood products and IVD. It is active in the organization and conduct of laboratory studies and collaborative studies for the standardization of international reference preparations and collaborates in the creation of WHO guidelines and WHO recommendations.
Experts from the Division of Virology and Microbiology involved in the authorisation and testing of vaccines are working in the WHO Collaborating Centre for Standardization and Evaluation of Vaccines. Furthermore, experts from the unit "International Coordination, Regulatory Service" support the WHO in its activities to strengthen regulatory systems particularly in Africa. The Centre supports WHO in developing international written standards and guidelines for the scientific and regulatory evaluation of vaccines.
Bilateral international Co-operation
The first agreement which was established in written form was made with the US Health Authority – the Food and Drug Administration (FDA) in 2006. The institute entered into two other agreements (Memorandums of Understanding) in the second half of 2010. One was entered into with the Chinese sister authority, the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP, meanwhile renamed into National Institute for Food and Drug Control, NIFDC), and the other one was entered into with the Health Sciences Authority (HSA) in Singapore. The increased collaboration with Asian authorities reflects the significance of a pharmaceutical market which is increasingly interwoven world-wide.
The above mentioned memorandums of understanding were followed in 2011 by an agreement on information exchanges with the Health Products and food Branch of Health Canada, and further commitments with Swissmedic (Switzerland) in 2012, the National Institute of Food and Drug Safety (NIFDS, Republic of Korea, 2013), the Scientific Center on Expertise of Medical Application Products (SCEMP, Russia, 2013), the Therapeutic Goods Administration (TGA, Australia, 2015) and the Federal Commission for the Protection against Sanitary Risk (COFEPRIS, Mexico, 2016).
Homepages of co-operation partners:
- COFEPRIS (Mexico)
- Food and Drug Administration (USA)
- Health Canada (Canada)
- Health Sciences Authority (Singapore)
- National Institute of Food and Drug Safety (Republic of Korea)
- NIFDC (China)
- Scientific Center on Expertise of Medical Application Products (Russia)
- Swissmedic (Switzerland)
Therapeutic Goods Administration (Australia)