Mutual recognition agreements between Western regulators would help ensure a safe API supply chain, according to the EFCG.
Speaking at this week’s CPhI Worldwide conference in Madrid, Gian Mario Baccalini called for all active pharmaceutical ingredients (APIs) to adhere to good manufacturing practice (GMP) standards under one global system.
Baccalini – the chairman of EFCG’s (European Fine Chemicals Group) Pharma Business Committee – said implementing one system for all is crucial not only for the safety of drugs, but also to allow compliant manufacturers to operate on a level playing field.
He told in-PharmaTechnologist.com the best way to gain harmony amongst the regulators is sharing inspection responsibilities.
“Many regulators now have mutual recognition agreements – for instance Canada and Australia have agreements with the FDA. If the FDA inspected a facility in Asia, it would be trusted by many other bodies for instance,” he said.
He went on to urge other organisations, such as the European Medicines Agency (EMA) to adopt the system.
“If you have all the regulators we can have enough people to satisfy the global needs,” he said.
Worth the cost?
Baccalini admitted that implementing such a system would mean additional costs for many producers. However, he believes industry will generally accept the proposals for the good of their business.
“All the active ingredient producers around the world must decide to adhere to GMP production,” he added. “Yes it would change the budget. It would cost a lot of money but from a strategic point of view everyone agrees this is needed. This would be a tremendous change because only the people who can make GMP would be accepted. We would be stronger through the entire system.”
He added that for the EU especially the changes could be a boon because they are currently competing with producers elsewhere – particularly in Asia – that are cutting costs because they are not GMP compliant.
“We have a lot of concern because in the generic field 70 per cent or more of API used comes from Asia,” he said. “We disagree totally that half the world is working with a very strict controllable GMP, but other part is not working in this way.”