Falsified Medicines Directive for APIs and Excipients
On 1st July, 2011, the European Commission issued amending Directive 2011/62/EU to Directive 2001/83/EC
for human medicines, to be implemented by the EU Member States by 2nd July 2013. This has become known as the Falsified Medicines Directive.
Whilst the FMD fell short of our expectations, we remain active to ensure the patient is protected and our Industry operates in a level playing field. We strongly advocate for mandatory inspections by EU authorities of non-EU API manufacturers.
The current Directive covering human medicines does NOT ensure that the APIs used in EU comply with European GMP wherever they are made. About 70% of all APIs sold in EU now come from non-EU sites. The use of many non-EU API sites is dependent on industry self-evaluation and open to corrupt practices.
DG Sante/EMA have been vigilant in their monitoring of Written Confirmations and have taken action to stop importation, for example from India. Mandatory inspections of EU API sites are performed by EU Regulatory Authorities but there are no mandatory inspections of non-EU API sites. All EU countries have transposed the FMD into national law. EFCG members have picked up new business as a consequence of FMD and ‘flight to quality’ by MAHs.
GDUFA II: EFCG Proposals
GDUFA I will expire in September 2017;
Talks around GDUFA II started with the US FDA who have called for input from a user perspective.
The EU fine chemicals industry (EFCG and APIC) has been invited to take part in the discussions with the FDA, along with its US counterparts.
We are gathering feedback from members in the EU and the US on their experience to share with the FDA. A crucial part of these talks are the DMF fees which have doubled since 2013 due to the decreasing number of DMFs. FDA reactions are still too slow
Industry wishes to enter into GDUFA II in order to accelerate approval of generic drugs, and ensure a more level playing field and their ANDAs and DMFs to be of higher quality filings thanks to a better dialogue with the FDA.
REACH:Guidance for the Strict Control Conditions for Intermediates
EFCG represents a very wide range of companies, large multinationals but especially SMEs. We therefore continue to advocate for a more flexible and proportional interpretation of the 2010 and 2014 ECHA guidance document on strictly controlled conditions for intermediates as well as for lighter and more flexible Reach Authorisation and Restriction procedures for smaller tonnage bands as this has the potential to negatively impact a lot of the smaller fine chemicals producing companies.
Voluntary Guidelines for Fine Chemical Manufacturers Worldwide
EFCG’s Agrochemical & Intermediates Manufacturers in Europe (AIME) committee has further developed its set of Voluntary Guidelines
for non-ISO-regulated fine chemical intermediates and active ingredients. They have added “Ethics” and “Labour” to the recommendations for business and manufacturing standards developed and supported by prominent fine chemical manufacturers in Europe.
EXCiPACT pharmaceutical excipient supplier certification
As founder members of the international industry consortium that launched the new EXCiPACT scheme and standards for GMP and GDP certification in January 2012, we have been intimately involved in its development and are determined to see it fully operative in 2013 as an independent, self-supporting industry association based in Brussels. At present it operates as a project within the IPEC Federation.
To better reflect the importance of Innovation across the EU Fine Chemical Industry, the EFCG Board set up its Innovation Committee in 2014. Amongst current activities is the application of a cutting-edge innovation methodology, TRIZ (Theory of Inventive Problem Solving) - a systematic process that develops creative thinking skills - to help us shape the future of our association and our activities and provide our members with a tool for their step-change innovation projects.
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