Regulatory Changes In - and For - China

There were some interesting sessions at this morning's keynote sessions at the ISPE-CCPIE conference in Beijing.

The Chinese State FDA presented a brief history of the Chinese GMP regulations, comparing these to other international regulations (e.g. WHO) and although they provided an outline of the new Chinese GMP regulations there was no commitment in terms of a date by which these will be made effective.

Cynics at the conference suggested after the session that this is because 90% of local Chinese companies would not comply with the new Chinese GMP regulations, but while the SFDA do appear to be keeping their options open regarding timing (and appear to be moving away from introducing a target date with a period of grace during which companies could move to compliance) a session from the US FDA gave a different picture.

Its 12 months since the US FDA set up shop (a field office) in China and although there are still only seven full time FDA staff in country - with only half of these conducting for-cause and high priority inspections - there appears to have been good progress in working with the Chinese State FDA (SFDA) as well as some of the Provincial FDA offices.

What we appear to be seeing is the Chinese authorities committing to address the regulatory/quality concerns that threatened to impact their export markets last year while also starting to address the reform of regulations in their home market, recognizing that the latter will take a while to address in a market consisting of literally thousands of (rapidly consolidating) manufacturers and distributors.

The US FDA and SFDA now meet on a monthly basis, with the SFDA acting as observers to some US FDA inspections. The US FDA is helping to fund training for the SFDA, reviewed the pending Chinese GMP regulations and have provided 10 GCP regulations for the SFDA to translate. This is all part of the US FDA strategy of helping to educate other regulatory agencies on the requirements of the US market and to help build inspection capacity (through the education of a cadre of SFDA inspectors trained in international regulatory expectations).

At the same time, multinational Life Sciences companies are sharing concerns about Chinese products with the US FDA, who are in turn discussing issues with the SFDA and there is also agreement between the US FDA and SFDA to focus on ten high risk products (mainly pharmaceutical, but some medical devices).
This co-operation provides evidence of the US FDA's desire to work more effectively with other regulatory agencies and will certainly start to address concerns about Chinese product.

At the same time it will also help the Chinese authorities to better regulate their own market, which is forecast to be world's largest by 2013 (behind the US and Japan). While 'rogue traders' operating out of China will undoubtedly be of continuing concern with respect to product quality and counterfeiting at least problems with the legitimate market are starting to be addressed.

Whatever people may think about the Chinese governments method of implementing change, there is no doubt that effective reforms can be implemented and probably more quickly than in many other markets. Although this is just the beginning there is no doubt that regulatory change is happening - which will be good for patients in China as well as the rest of the world.