Regulatory reforms to reshape drug manufacturing in China says expert
China has been phasing in quality rules for pharmaceutical manufacturers over the past few years, starting in 2011 when the CFDA introduced the requirement that drugs must be made in compliance with cGMP standards.
Under the laws 1,900 facilities have already shut down according to David Deere, Chief Commercial Officer at US-based market access firm PaizaBio, who predicted that additional rules introduced last year will see more closures.
“The overwhelming majority [of drugmakers in China] will not have the technical nor financial resources to comply with CFDA cGMP - which is very similar to EU-EMA cGMP - so expect 1,000's more closures/non-renewals and consolidations.”
But any reduction in capacity will be short lived according to Deere, who said the closure of smaller firms will allow the bigger players and the cGMP compliant handful of CMOs that operate in China to take control of the market.
Sterile injectables
The trend will be most pronounced among manufacturers of sterile injectables which, as Boehringer Ingelheim and Hospira have discovered – is a challenge for companies that are able to invest in quality.
“Injectables are a completely different resource and technical level” Deere said, adding that “unsurprisingly there are currently very few aseptic manufacturers in China.”
China wants to supply its own market while targeting opportunities to grow its large scale finished biopharmaceutical product capabilities and become a major exporter to Asia and, eventually, the West Deere said.
“Today they are largest supplier of API [to the West], while India is the largest supplier of finished pharmaceutical product. China wants to ‘leap frog’ the Indians and focus on biological and large molecules which are the hardest to make and most valuable.”
Training Programme
It is in such an environment that PaizaBio is launching the Trans-Pacific Aseptic Institute of Training (TPA-IT), a formal technical education program based at Ausia BioTech sterile injectable facility in Hangzhou.
Training at what the firm describes as the “Sterile University” will focus on making injectables to Western quality standards and, according to Deere, with Ausia’s $8m full scale training facility will compete against other global training centres.
“No pharmaceutical company or CMO in the world has a similar facility. The US PDA (Parenteral Drug association) has one small commercial company operating in North Carolina, and the Irish Government offers similar training from its Dublin-based [‘biomanufacturing flight simulator’] centre.”
He continued: “The first class is in March. While the emphasis will be Asia, since it is in English, and much cheaper than PDA, which always sells out, we expect Western clients in the future.”
Foreign Innovation Fast-Track
The quality rules were introduced in conjunction with an expanded fast-track review policy that promise speedier review for pharmaceuticals manufactured in China.
This is also likely to change China’s manufacturing landscape according to Deere, again citing CMOs as likely beneficiaries.
“80% of all Western pharmaceutical companies use CMO's to perform injectable manufacturing for their products [as] aspectic fill-and-finish is a highly technical, highly automated, resource and training intensive operation, and few products have the volume to support in-house full commercial operations .”
