UK Developing Backup Plan to New European API Import Rules

Faced with the possibility of drug shortages, UK regulators are developing contingency plans to new EU importation rules for active pharmaceutical ingredient (API) makers.

The EU’s Falsified Medicines Directive takes effect on July 2 with new requirements for importing APIs into Europe. The directive requires API makers from outside the EU to get written confirmation from their countries’ regulators that their manufacturing sites meet European good manufacturing practices (GMP).

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said Saturday it is developing contingency plans that would allow certain API imports if they are needed to address a shortage.

The short-term plan will affect API makers located in countries not covered by a written confirmation or that haven’t been assessed by the European Commission (EC) as having equivalent GMP standards.

If a UK drugmaker’s API source is at risk, that drugmaker must provide evidence to the MHRA that:

• The API manufacturing site has been audited in the past three years by the drugmaker and meets EU GMP standards; and
• The site is in compliance with a recognized regulator such as the FDA.

The FDA requested a “third country” exemption from the API import rules in January, but the EC has yet to make a decision. So far only Switzerland, Japan and Australia have made the list of third countries, and Israel and Brazil are also awaiting final confirmation, according to the EC.

MHRA has said that it may need to inspect about 1,200 sites in order to comply with the API rules.

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