Pharma Industry Calls for a Mutual Recognition Agreement on GMP in EU-UK Future Relationship

The pharmaceutical industry in Europe has worked to support the EU27 and UK to reach an agreement that will allow patients to receive medicines and medical technologies without disruption and provide long term co-operation between the EU and the UK in areas such as research, clinical trials, pharmacovigilance and access to talent. European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe and Association of the European Self-Medication Industry (AESGP) has stated that the European pharmaceutical industry has worked to support the EU27 and UK to reach an agreement that will allow patients to receive medicines and medical technologies without disruption.

In the coming months, the EU and UK should conclude an agreement that secures the greatest regulatory alignment and cooperation on human medicinal products. Reflecting precedents from previous agreements, an FTA should also include ambitious provisions on sharing of data, the protection of intellectual property (IP), customs facilitation, as well as rules of origin (RoO). The EU and UK should establish a working group on pharmaceuticals and medical devices as per the EU-South Korea Free Trade Agreement.

At the start of the negotiations, the organisations have stated they wish to highlight one critical recommendation for immediate action, namely completing a Mutual Recognition Agreement (MRA) on good manufacturing practice (GMP) as:

• An MRA on GMP would cover waiving batch and import testing by manufacturers and OMCLs (official medicines control laboratories) and recognition of GMP inspections between the EU and UK (covering EU and UK territories, as well as third countries).
• This would have an immediate positive impact on the resources of the regulatory agencies, the European Medicines Agency (EMA), National Competent Authorities (NCAs) of the EU, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and on the pharmaceutical sector, with benefits for patients in terms of timely access to medicines and treatments, and would help to secure the continuity of supply of medicines in both markets.
• The resource savings forregulators should allow for the agencies to work together to focus on high-risk sites in need of inspection, including in third countries, and to ensure resources are committed to addressing such high priority needs. This would also be in line with current EU practice on MRAs, as further outlined below.

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