EFCG calls for mandatory inspection of API plants
pharmafile | November 13, 2012 | News story | Manufacturing and Production |Â Â API, EFCG, EU, FMDÂ
The European Fine Chemicals Group (EFCG) has called for all active pharmaceutical ingredient (API) manufacturing facilities to undergo mandatory inspections.
The trade organisation also wants national regulatory authorities to develop a mutual recognition agreement so agencies can “share scarce inspection resources and to avoid the present duplication”.
The measures proposed by the EU Falsified Medicines Directive do not go far enough to ensure “the quality of APIs and medicines containing them meet the high standard recognised by developed economies”, it says.
In a new white paper, the industry group reiterates its concern that many of the facilities providing ingredients for medicines sold in the EU “have never been inspected by the EU authorities and are unlikely to meet the required EU GMP standards for many years to come”.
The FMD includes a requirement for regulatory authorities to certify that APIs imported into the EU are made at facilities which comply with Good Manufacturing Practices (GMP), but the EFCG is concerned that legislation still relies on auditing of API suppliers by drugmakers or third-party organisations, rather than inspections by regulatory agencies.
Moreover, the certification approach is uncontrolled, is not checked for authenticity and has a number of other flaws, including an unlimited validity period, says the white paper.
It also puts a modest €2.6 million price tag on the cost of carrying out such inspections over a three-year period via an MRA approach, which is considerably lower than the cost predicted in the FMD impact assessment.
A key reason for the reduction is that the true number of API facilities serving the EU is less than 1,000, claims the EFCG, a much lower figure than the 15,000-20,000 estimated by the EU.
Couple that reduced workload with an extension of already-successful shared inspection and MRA pilots by the EMA, FDA and other regulatory bodies, and mandatory inspections could have ‘formed the basis’ of the FMD’s handling of API imports, argues the paper.
Phil Taylor
Related Content
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s …
EU approval granted for rare kidney disease treatment
The EU has granted marketing authorisation (MA) for Filspari – CSL Vifor and Travere Therapeutics’ …
