FDA to accept drug plant inspections by Poland, Slovenia
- Drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the Food and Drug Administration, allowing the agencies to share information gathered through their oversight of manufacturing facilities.
- Poland and Slovenia are respectively the 21st and 22nd European countries acknowledged by the FDA under a mutual recognition agreement inked between the U.S. and EU. to reduce redundant inspections and facilitate greater information sharing.
- The EU determined the FDA was capable to carry out Good Manufacturing Practice inspections at a level equivalent to EU regulators in June 2017. The FDA hopes to do the same for authorities in all 28 EU member states by this July.
The FDA first accepted inspections carried out by EU member state regulators in November 2017, recognizing eight authorities including those of the U.K., Spain, Italy and France.
Since then, the U.S. agency has steadily lengthened its list of recognized counterparts, most recently adding five last November. Poland and Slovenia were recognized earlier this month, on Feb. 7, according to an FDA website.
Mutual recognition, while a bureaucratic step, carries the potential to streamline oversight of drug regulation at a time when the industry is increasingly global. Many of the raw ingredients contained in small molecule medicines are made in India and China, while the biotech sector of the latter has growing ambitions to become a bigger player on the world stage.
Ensuring pharmaceutical and biotech products are produced to international standards, then, is a particularly heavy burden for any one country's regulator — a problem potentially lessened through mutual recognition.
Between 2011 and 2016, for example, more than 1,300 API inspections were carried out by European authorities, the FDA, the World Health Organization and the Australian health agency at 458 manufacturing sites considered to be of common interest.
Current cooperation between the FDA and EU member state regulators stems from a 1998 agreement signed between the U.S. and European Community which contained provisions for mutual recognition of GMP inspections.
Those provisions weren't ever fully implemented, however, until a 2017 amendment allowed the agencies to move forward.
With Poland and Slovenia now recognized, the FDA still has to agree to accept inspections by Bulgaria, Cyprus, Germany, Luxembourg, the Netherlands and Slovakia.
- BioPharma Dive US widens recognition of EU drug plant inspections
- BioPharma Dive As India, China drug industries mature, FDA scrutiny an overhang
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