Hearing on the ministerial draft bill concerning the Medicinal Products Act Amendment
The Federal Ministry of Health (BMG) held discussions with experts on the rules contained in theministerial draft bill on the Fourth Act Amending the Regulations on Medicinal Products and Other Regulations (Medicinal Products Act Amendment) that pertain to the implementation of the EU regulation governing the conducting and supervision of clinical trials in Europe. It became clear during the hearing that the changes should go into effect as early as this summer.
During the hearing at the start of January, BIO Deutschland was able to raise the points that it had presented in its statement on the Medicinal Products Act Amendment. The BMG will examine the points raised and depending on the assessment, make revisions in the cabinet draft that is expected to be completed in March. The Bundestag will then deliberate on the proposed legislation. According to the current timetable,the final vote in the Bundestag is planned for the end of June, followed by the final consultation in the Bundesrat in July.
The ambitious timetable is a result of EU-level implementation taking place in the background. In the future, manufacturers must submit their appliction dossiers for the authorisation of a clinical trial to a central electronic portal, which is currently being developed by the European Medicines Agency (EMA) in collaboration with EU member states and the European Commission. The EMA plans to have the new portal functional by mid-2018. Thus the EU regulation must be fully implemented by October 2018 at the latest. The BMG believes the necessary revisions in Germany will be a lengthy process and require “a lead time of probably two years”. Among other steps,a new registration procedure for ethics committees must be established. In order to keep to this ambitious timetable, the Medicinal Products Act Amendment must be adopted by summer 2016.