(Source: EMEA. Click To enlarge.) BNET reported last week that the U.S. FDA has just two inspectors working full time in China. It is not known how many inspectors Europe has in China. China has a reputation for producing shoddy, sometimes poisonous drug products in a business environment that lacks transparency, but companies are moving their R&D and manufacturing facilities there anyway.
The European commission sought public comment on what it should do to beef up inspections of meds made in China a couple of years ago. The papers associated with that move don't give a number for inspectors in China, but many of them imply that no one knows how many are there, or that inspectors only show up after a scandal emerges, or the number is zero. In 2008, EMEA (the European version of the FDA) inspected only 19 sites outside Europe or America, according to its annual report.The consultation document gave no numbers but said:
Today, inspections by competent authorities are restricted to cases of suspected non-compliance with GMP [good manufacturing principles].The Active Pharmaceutical Ingredients Committee submitted this statement in response:
As India and China are supplying around 70 - 80% of the off-patent APIs used in EU medicines, we have long-argued for an increase in the number of official inspections of manufacturers of APIs in such high risk countries.
The risk of non-GMP compliance in India and China is high due to the prevalence of lower GMP standards and the existence of numerous API manufacturers in those countries who are hardly or not complying with any GMP and registration principles. There are strong indications that many of such highly non-compliant manufacturers are presently supplying the EU market, mainly through traders and brokers, while not being inspected.APIC added that unfair competition was driving European manufacturers out of business in favor of their less strict Chinese rivals. Italy's Chemical Pharmaceutical Association said:
The law already provides for such inspections, but the lack of resources and the inclination of the EU authorities to inspect based on geographical proximity rather than risk to the patient, works against effective enforcement.In 2008, the Europeans recommended a raft of changes. But the recomendations contained some weak provisions, including one section in which companies can pass a portion of their inspections simply by providing a letter from Chinese authorities:
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community, and that the plant is subject to control and enforcement ensuring that those good manufacturing practices cannot be circumvented.It is not clear whether the changes were ever implemented. EMEA's web page notes only that the rules were proposed, not that they were passed.
How many European Union inspectors should there be in China making sure that drugs made there for Western patients are up to standard? At least 40, according to OutSourcing-Pharma.com.
Amalia Sartori, rapporteur of [the European Union's Committee on Industry, Research and Energy], added to Outsourcing-Pharma that she understands that 40 inspectors at the European Union (EU) level would be needed for the inspection programme.
However, neither the mandatory inspection programme nor the verification of EU traders directly tackles the problem of unapproved overseas API plants. Products from these 'shadow factories' can potentially enter the legal supply chain through the complex network of overseas traders.UPDATE: The EMEA is not the only European authority doing inspections in Asia. The European Directorate for the Quality of Medicines and Healthcare said in November 2009 that it inspected 180 sites, mostly "in Asian countries," but did not specify the time period or the countries inspected. Download the EDQM statement here. Hat tip to Pharmalot.