EFCG calls for stricter rules on API and excipients made outside the EU

Europe's fine chemicals trade body is participating in discussions on resourcing audits

Over 70% of all APIs sold in the European Union (EU) now come from non-EU sites and the current Falsified Medicines Directive (FMD) 2011/62/EU does not ensure that the APIs used in the EU comply with European GMP wherever they are made, said European Fine Chemicals Group (EFCG) Board Member and Chairman of EFCG Pharma Business Committee Dr Gian Mario Baccalini at CPhI Paris.

Dr Baccalini, who is also President and CEO of Italian fine chemicals company Euticals, said use of many non-EU API sites is dependent on industry self-evaluation and open to corrupt practices. 'They require stricter enforcement by EU authorities plus tough sanctions to punish offenders,' he suggested.

Dr Baccalini called for more trained inspectors to detect falsification and fraud. Speaking on behalf of ECFG members, he also called for the law to be changed either to include mandatory inspections paid for by industry if needed (similar to the GDUFA scheme introduced in the US) or to arrange Mutual Recognition Agreements (MRA) with those countries with EU GMP standards.

He said that despite the EU-US Transatlantic Trade & Investment Partnership (TTIP) talks that started in July 2013, it had been a very slow negotiating process and that while the FDA remains opposed to an MRA, it wants Mutual Reliance a half-way house where inspections would still take place. He added that a joint inspection programme has been recommenced and joint inspections are pencilled in for Sweden, Hungary, Croatia and Germany.

Future impact on excipients

Excipients may be affected in much the same way as APIs, said Tony Scott (Tony Scott Associates), an adviser to EFCG/Cefic and Member of the Board of voluntary international scheme EXCiPACT, set up to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients.

Increasingly the regulators expect Marketing Authorisation Holders to secure their supply chain and they see physical audits as an essential component in understanding and controlling supply chain risks. The EU FMD also requires quality risk assessment of suppliers and specifically mentions excipients, while in the US the ANSI/NSF 363 committee is currently developing a cGMP standard for excipients.

Scott said it is clear that implementing risk management programmes to secure the supply chain will result in a substantial increase of physical audits and the economic burden associated with these requirements are having an impact on both manufacturers and users.

He sees EXCiPACT as a way to reduce this burden and said that ANSI/NSF 363 is convergent with the EXCiPACT standard and that the UK MHRA had also expressed the view that third party certification schemes could assist manufacturers in achieving compliance with GMP at reduced cost, time and resource. The regulatory position in the US and Europe is very supportive of independent third party auditing schemes if they meet two core principles of auditor competency, and certifying body independence and freedom from conflicts of interest, he said.

'The EXCiPACT Certification Scheme has built these two principles into its core and meets these regulatory requirements,' he said, adding: 'It may not replace all pharmaceutical company audits but the scope, duration and quality of the audit is greater than typical excipient supplier audits and the frequency of audits is yearly higher than the industry average.

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