On March 13, China State Council released a draft plan to reshuffle government ministries, specifying the duty of China Food and Drug Administration (CFDA). At that night, Grace Palma, CEO of China Med Device, traveling in Beijing, is interviewed by Zachary Brennan, Managing Editor of Regulatory Focus, from Regulatory Affairs Professionals Society (RAPS).
China Plans CFDA Changes, Reshuffling of Ministries
Posted 14 March 2018 | By
China’s State Council on Tuesday unveiled a draft plan to reshuffle government ministries, with the China Food and Drug Administration (CFDA), along with several other administrations, restructured as the National Market Supervision Administration.
The draft would mean the State Council will be composed of 26 ministries and commissions.
Grace Fu Palma, CEO of China Med Device, a Boston- and Beijing-based consulting company focused on regulatory and market access for China, explained to Focus that the changes will mean CFDA is no longer a standalone department but will be part of a larger unit.
And though the changes may not impact device or pharmaceutical approval timelines, she said changes will allow CFDA to focus more on the lifecycle of products.
Leon Lei of China Med Device added: “Previously, the registration of medical device and pharmaceuticals had to go through the Administration for Industry & Commerce, which was also partly conducting administrative penalties; Administration of Quality Supervision, Inspection and Quarantine, which was responsible for inspection and quality issues. Now they are supposed to be integrated as a whole.”
Palma also said she spoke with CFDA section heads recently and that they do not think these high-level changes will affect their day-to-day work, but previously announced efforts to increase transparency around regulatory decision making will.
CFDA is also setting up systems to make sure manufacturers comply with the reporting of adverse events.
Palma noted that CFDA is adding more than 100 experts on the device side who will need training, and that food will no longer be under the administration’s purview. In addition, CFDA has looked to increase inspections of foreign entities and penalties for noncompliance.
“The government is spending tens of millions of US dollars to renovate their systems to make them more transparent … but timelines [to approval] are not coming down in the immediate future,” Palma said.
She also noted that CFDA is becoming more receptive to feedback from US and multinational companies and may look to establish a formal channel for such feedback, in addition to working with companies to improve approval timelines.
According to China Daily, national legislators are scheduled to vote on the draft plan on Saturday.
Other Recent Developments
In addition to the structural changes and transparency efforts CFDA also forged a new memorandum of understanding with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month.
And last October, in addition to the transparency effort, China announced plans to accept data generated from clinical trials run overseas. Other reforms aim to improve the efficiency and quality of studies run within China.
The State Council is also planning to aid developers of innovative drugs by protecting intellectual property through a patent system designed to cut the risk of infringements while encouraging the development of generic medicines.
CFDA also drafted guidance on postapproval manufacturing revisions, echoing draft guidance posted by the US Food and Drug Administration (FDA), and proposing three tiers of changes to production processes and detailed steps companies need to take.
Last August, CFDA also detailed the data management standards it expects companies to follow when researching, developing, making, distributing and monitoring the use of medicines.
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.