Chinese manufacturers looking to enter European markets must improve their quality standards, according to consultancy firm Diapharm.
The Münster, Germany-based firm was visited last week by the Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and has announced it is opening an office in Shanghai next year to serve the growing number of local drug and ingredient manufacturers planning to move into Western markets.
Managing Director Ralf Sibbing told Outsourcing-Pharma.com the firm would initially offer two main services to Chinese clients: achieving EU current Good Manufacturing Practice (cGMP) at their facilities, and helping them set up “satellites” in Europe to aid drug Marketing Authorisation Applications (MAAs).
“[China’s pharma industry] is talking about trying to improve quality,” he said. “China’s 12th five-year plan detected the pharma industry had grown up really fast but maybe missed a bit on the high quality standards the West requires.
“[Manufacturers] would like to improve this in the next few years,” but need to know “what to take into account when improving quality.”
So far Diapharm has a number of ongoing projects advising and assisting the set-up of GMP compliant facilities, as well as from a number of larger drugmakers looking to set up a Germany-based subsidiary, Sibbing said, though was unable to tell us with which firms due to client confidentiality.
Concerns regarding Chinese firms and their understanding of European regulations were brought up recently by German auditing firm blue inspection body , who the CCCMHPIE - representing 2,400 Chinese pharmaceutical companies - also met up with on last week’s visit.
China has long been a key producer of ingredients for the West but increasingly companies are expanding their operations globally. One strategy is teaming up with a Western firm in a joint venture, such as one undertaken in June between Zhangjiang Biotech & Pharmaceutical Base Development Company and Boehringer Ingelheim, and WuXi’s JV with MedImmune last year.
However, Sibbing said, “many companies are not willing to go into a JV” as they may lose their independence and flexibility, as well as create issues stemming from the Chinese government having to hold a majority share in a firm. “Those who wanted to co-operate with multinationals already did.”
He continued: “We are a more flexible and individual solution, offering faster and more flexible solutions [for Chinese drugmakers],” adding the “very good relationship with the CCCMHPIE” as an advantage for the commercial services Diapharm offers.