The regulatory environment for EU manufacturers of fine chemicals has become the toughest in the world. Several hundred new pieces of legislation have been enacted since the 1990’s, the most important being REACH (Registration, Evaluation and Authorisation of Chemical substances).
EFCG supports the objectives of REACH and, in association with Cefic, we are committed to help our members to minimise the consequential increase in business costs.
Pharmaceutical products are exempt from REACH but not their intermediates. The laws governing the supply of active pharmaceutical ingredients (APIs) for use in the EU already requires all global manufacturers wishing to sell in the EU to comply with Good Manufacturing Practice (GMP) equivalent to ICH Q7 as well as other product registration regulations.
A new human medicines Directive,2011/62/EU was published on 1st July, 2011 - the so-called Falsified Medicines Directive - to control the supply to the EU of APIs, excipients and final medicines and to prevent the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source. (see also Hot Topics)
In 2004 EFCG raised the first red flags about sub-standard Active Pharmaceutical Ingredients (APIs) entering Europe from India and China. Twelve years on, it appears that risks to patients from non-compliant bad quality APIs have been substantially reduced and that the playing field is levelling out.
EFCG Press Conference CPhI 2015: "API" day for Europe as Big Pharma returns in search of quality (by Dan Stanton)
EFCG Press Conference CPhI 2015: Outlook in Europe for API Manufacturers is positive, says EFCG