Canadian public health officials have announced the expansion of Health Canada's regulatory authority to inspect and require all active ingredients(AIs)-sometimes referred to as active pharmaceutical ingredients (APIs)-to meet current good manufacturing practice (CGMP) standards.
The change in some ways reflects a change in the way pharmaceutical products are now manufactured. Many facilities will manufacture just AIs or APIs, sending the finished product to a second manufacturing facility that then turns the ingredients into a finished product. Compounding this trend, these AI/API manufacturers are increasingly moving abroad, making it more difficult for regulators to track and inspect a drug's entire supply chain from start to finish.
The new requirements will require all AIs used in pharmaceutical products sold in Canada to have met CGMP standards regardless of where they were produced-either in Canada or internationally.
"These stronger regulations will improve the safety of drugs used by Canadians and their families," said Leona Aglukkaq, minister of health. "They will help make sure that all AI in drugs sold in Canada, no matter where they come from, are manufactured according to high standards."
Aglukkaq said the new requirements reflect regulators' concern that AIs are a weak point in the current supply chain. "There has been a growing concern over the quality of AI by health regulators around the world," explained Aglukkaq. "These amendments show our government's commitment to help protect the health and safety of Canadians and strengthen partnerships with other health regulators."
Similar concerns have been raised by European API manufacturers as recently as this week. The European Fine Chemical Group, an organization representing chemical manufacturers, called this week for an international inspection regime for APIs. The group said it was increasingly concerned about the globalization of API manufacturers beyond the regulatory oversight of established regulatory authorities, and pointed to failings in the system-such as the case of tainted Heparin in the US-where weak API oversight had resulted in public safety problems.
[For more on this topic, please see Regulatory Focus' 13 November 2012 story, "Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain."]
That inspection regime would utilize the International Conference on Harmonization's Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, and Aglukkaq said Health Canada will adopt the guidance as well.
"The international community of pharmaceutical regulators and manufacturers has developed and adopted GMP guidelines specifically for AI," she explained. "These amendments will bring Canada into line with its international partners."
Aglukkaq's statement marks the second time this month Health Canada has stated its intentions to strengthen the regulations of APIs. In October 2012, Health Canada launched a consultation on a draft guidance on GMPs for APIs, which it said were based on the ICH Q7 guideline (2009, version 2). That consultation ends on 5 January 2013, and would presumably be the guidance applicable for all manufacturers for APIs under Aglukkaq's 15 November announcement.