China’s new regulatory process could cause delays, RDPAC warns

Concerns have been raised in China that regulatory delays could defer the introduction of new drugs into the country by up to two years.

Bloomberg reports that foreign pharma companies operating in China, such as German pharma giant Bayer, are concerned over recent delays which have seen more than 30 applications held up, according to figures from Chinese trade group R&D-Based Pharmaceutical Association Committee (RDPAC). The group said that some companies have received notices on the added step in the regulation process, while other milestones are also likely to be delayed. It cites McKinsey & Co. estimates that the top 15 pharma multinationals have annual sales of about 100 billion renminbi ($16 billion) in the country.

Joseph Cho, managing director of RDPAC, said: “Some of these investment plans are worth hundreds of millions of euros, and that’s why this has caused a big reaction from our member companies. It is hard to understand from an international perspective that a practice implemented for 12 years was suddenly changed, without notice or a transition period.”