Regulatory

Regulatory

At any time, there are more than 300,000 clinical studies happening around the world. The process for bringing new pharmaceuticals to the market is prolonged due to regulation placed on the drugs sector in order to protect public safety. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) is the legal narcotics and medical device regulatory authority in Germany. According to the BfArM, “They are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.”

The effects of Brexit are being felt across many different industries in Germany, particularly in the pharma regulatory sector. The BfArM is one of the major licensing authorities in the EU and actively supports the European Medicines Agency in all key areas of drug authorisation and drug safety, together with the Paul Ehrlich institute, more than 480 experts bring their expertise to around 130 scientific bodies of the EMA.

According to Prof. Dr Karl Broich, President of the BfArM, “The organisation makes significant contributions to the supply of patients in Europe with safe medications and will increase these contributions in the years to come after Brexit and the loss of the British licensing authority, the number of authorisation processes will also increase, for Germany in particular.”

Increased demand for regulation following Brexit will likely see substantial growth in the market over the next number of years. At the moment the BfArM employs roughly 1,100 employees across many different specialisms including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants, administrative staff. More than 130 of their nearly 1,100 employees will reach the age of 65 within the next 5 years, in other words, 12 % of the staff will retire in the near future. This will free up numerous jobs that will need to be filled as Europe becomes more reliant on Germany to spearhead regulation following the UK’s exit of the EU.  

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the regulatory industry in Germany and across Europe.

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