MHRA Details Plan for Enforcing EU API Import Rules
To comply with the EU’s new import rules for active pharmaceutical ingredients, the UK’s Medicines and Healthcare products Regulatory Agency plans to review APIs during plant inspections rather than rely on assessments made at the border.
The EU’s Falsified Medicines Directive took effect July 2, requiring all API makers operating outside the EU’s 28-member bloc to get written confirmation from their national regulators that their facilities meet EU good manufacturing practice standards.
The MHRA will review imported APIs during the “inspection of manufacturers and, where there is a risk trigger, at inspection of [API] importers and distributors,” the agency said.
The MHRA is the competent authority for APIs and pharmaceuticals, “not UK border control,” agency spokesman Matthew Niizeki said, explaining the move.
Niizeki said Germany and Spain have adopted the same approach.
The MHRA previously said it could inspect roughly 1,200 sites in order to comply with the EU’s new rules. The EU granted the U.S. Food and Drug Administration a waiver to the new import rules earlier this year, relieving U.S. API makers from having to file cumbersome GMP documentation before importing products to EU markets.
The MHRA has voiced concern that the additional inspection requirements could “in some instances make the sourcing of [APIs] from some third countries difficult,” leading to drug shortages.
To prevent shortages, the agency has adopted contingency plans that apply to third-country API makers that are not covered by a written confirmation, reside in an exporting country that hasn’t been assessed by the European Commission as having EU-equivalent GMP standards, and lack a certificate of compliance with EU GMPs.
The plan was initially floated in June. Drugmakers must provide evidence that they or a third party audited the API manufacturing site within the past three years and that it meets EU GMPs. Drugmakers must also show that the API site is in compliance with a recognized regulator such as the FDA.
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