News about GMP/cGMP

The Committee’s report, ‘The impact of Brexit on the pharmaceutical sector’ finds that leaving the EU without an agreement for the industry would diminish access to markets, including £11.9billion of exports and to more than 446million potential patients and consumers in the EU. British patients’ access to medicines would also be at risk, with nearly three-quarters of pharmaceutical imports coming from the EU.

Drug costs could be significantly impacted

The report concludes that the prospect of regulatory divergence from the European Medicines Agency (EMA) is the deepest concern for the industry, which would mean pharmaceutical companies needing to duplicate their facilities and roles across the UK and EU. Drug costs could be significantly impacted. A separate regime could impose extra costs of £45,000 for each new product released, making the UK an unattractive market for new and innovative medicines. While the Government has indicated its desire for continued cooperation, the Committee calls for a continued form of membership of the EMA as a priority, and recommends that the Government seek to retain a presence for the EMA in the UK after its relocation to Amsterdam.

Source:

UK Parliament - Business, Energy and Industrial Strategy Committee - News