19 / 2016
The European Voluntary Harmonisation Procedure for clinical trials (VHP) has become established since many years: In the meantime, the 1000th application for the evaluation of a clinical trial has been received in several European countries. The procedure which was developed under the auspices of the Paul-Ehrlich-Institut (PEI) has been available since March 2009. It fosters simultaneous initiation of the authorisation procedure for clinical trials in more than one European country by submitting one application. The Paul-Ehrlich-Institut co-ordinates this procedure for all medicinal products in the name of the Heads of European Medicines Agencies (HMAs).
Developing new medicinal products is a long and tedious process. After a pre-clinical phase of development and manufacture in conformity with GMP ("Good Manufacturing Practice"), they are required to be subjected to a number of clinical trials for efficacy and safety. Every country within the European Economic Area, in which such a clinical trial shall be conducted, requires a national authorisation. While a separate procedure of validation, assessment, request for information, and approval/rejection was required for each country, the Voluntary Harmonisation Procedure has for several years been a tool for the initiation of an authorisation procedure in the European countries selected by the applicant for conducting the clinical trial. The procedure was developed by the 'Clinical Trials Facilitation Group' (CTFG), a working group of the HMA ('Heads of Medicines Agencies') under the auspices of experts from the PEI. This harmonisation reduced the period required for the authorities up to the authorisation of a multinational trial to 60 days in all EU countries involved. Meanwhile, around 20 % of all applications for clinical trials to be conducted in more than one European country are submitted using the VHP.
"I'm very pleased that the Voluntary Harmonisation procedure has in the meantime been so well accepted by applicants world-wide, thus reducing the period required up to the authorisation of such multinational studies"
, said Dr Hartmut Krafft, head of the Unit 'Clinical Trials' of the Paul-Ehrlich-Institut.
"The VHP served as a model for the procedure to become applicable with the new regulation on clinical trials in future for the authorisation of multinational European clinical trials in Europe. The PEI is proud of having contributed to this success by its smooth VHP co-ordination"
, added Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut and head of the HMA Management Group.
Press Contact:
Paul-Ehrlich-Institut
Press Office
Dr. Susanne Stöcker, Dr. Corinna Volz-Zang, Brigitte Morgenroth
Paul-Ehrlich-Straße 51-59
63225 Langen
GERMANY
Telefon: +49 6103 77 1030
Telefax: +49 6103 77 1262
Email: presse@pei.de
The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.
The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).
Updated: 01.12.2016
