The impact on Regulatory ecosystems in the UK and EU

Is it the time to be alert for drug and medical device manufacturers associated with the European Union (EU) and the United Kingdom (UK)? As Britain voted to leave the EU, the situation seems to be uncertain for drug/pharmaceutical companies to plan ahead with the regulatory processes, at least for a while into the future.

The first and foremost would be the impact of Health Authorities relocation. Resulting from the referendum, to reduce the administrative hurdles, the European Medicines Agency (EMA) will have to relocate from London. On the other hand, the Medicines and Healthcare products Regulatory Agency (MHRA) of UK will have to decide whether to continue conducting site inspections for manufacturing of drugs and clinical trials alongside EMA or develop UK’s own drug approval system.

As the UK decided to move on from the European Union, the major impact we can predict is that Britain could face uncertainties right from the manufacturing, testing, and release of medicines into the market and to conduct clinical trials outside the UK, approaching for health authority inspections, understanding the patents ecosystem, and obtaining product licenses.

On the other hand, it could even be a severe setback to EU’s drug / medicines approval processes as the industry anticipates that the Brexit could snarl the regulatory system and create uncertainty among operational procedures at the EMA which might result in complexities and confusion in the near future.

Whatever may be the implications, navigating through the regulatory ecosystem in the UK and the EU regions in the current uncertain scenarios might be like wading through the unknown waters for the manufacturers who are new to the market. To safeguard and streamline your compliance efforts from the unforeseen situations, get to the roots of improvised or amended regulations. Plan your Regulatory pathway for the UK and the EU with the help of a global regulatory partner.


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