Opposition mounting to EU’s API import regulations
pharmafile | August 7, 2012 | News story | Manufacturing and Production |Â Â API, EU, TBT, WTO, manufacturingÂ
Changes to the EU’s rules governing the importation of active pharmaceutical ingredients (APIs) are being opposed by the governments of India and China, who are reportedly planning a formal protest to the World Trade Organisation (WTO).
The changes are part of the implementation of the EU falsified medicines directive and are due to come into effect in July 2013, and were prompted by high profile safety scares such as the contaminated heparin incident that led to dozens of deaths around the world a few years ago.
At the centre of the disagreements is a controversial new template for use by third country competent authorities to certify that the APIs being managed by companies in their jurisdictions comply with EU standards.
The template includes a statement by the third country authority that the standards of good manufacturing practice (GMP) applicable to an API supplier’s manufacturing plant “are at least equivalent to those laid down in the EU”.
With a sizeable proportion of bulk APIs used in the EU sourced from suppliers in India and China there is concern that firms – and particularly generic manufacturers – may find some APIs are hard to obtain once the regulations come into effect.
The UK’s Medicines & Healthcare products Regulatory Agency recently expressed its concerns about the initiative in a letter to the EC, saying that: “exporting countries may be unwilling to participate in the scheme as it increases their regulatory burden”, and recommending that the Commission engage ‘much more extensively’ with third country authorities to ensure the written confirmations are in place by the deadline.
The European Commission is now apparently committed to meeting the July 2013 deadline as the new rules are enshrined within EU law, and it is understood that only a handful of competent authorities have so far submitted confirmation statements, with respondents including Israel and Switzerland.
China and India are said to be planning a WTO appeal under the technical barrier to trade (TBT) provisions, which try to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles to commerce, at the next WTO meeting.
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’ …
