Pharma & Biotech
A variety of consultation channels are offered by the CDE to enhance the support of technical guidance and services to applicants.
New drug clinical trial applications 2020 annual report indicated a total of 2602 clinical trial applications received by the CDE.
China innovative drug approvals require pre-NDA meetings carried out in the application to address the common pharmacology issues
Improve the management of the electronic filing for drug registration applications, the NMPA developed and promoted the eCTD.
The NMPA has developed and built an API production and supply information collection module in the drug information collection platform.
The State Administration for Market Regulation addressed the innovative development plan actions for drugs and medical devices in the Greater Bay Area.
Cisema has the capability to help you comply with Hong Kong MDACS requirements and expand your businesses in the Greater Bay Area
From October 25th to November 1st, China SAMR publicly solicited opinions upon its release of the third draft on the measures of advertising review management for health food, FSMP, drug products and medical devices.SAMR had been open to public feedback from March 13th to April 13th and June 6th to June 26th followed by adjustments made to the first and second draft.As revealed in the previous announcement and drafts, SAMR aims to formulate a major regulatory reference in future by requiring compliance for advertising health food, FSMP, drug products and medical devices including, but not limited to, the following conditions:Content (e.g. name, application scope, composition):
- Must match the details in NMPA registration documents, certificate and IFU
- Must be legal and truthful
- Must not mislead or deceive users
Disclaimers necessary:
- Personal use devices:g. ‘Please read the instructions before using the device’ or ‘Please seek the advice of a healthcare professional when buying and using this device’
- If safety instructions & precautions are mentioned in NMPA certificate, they must be displayed clearly in the advertisement
e.g. ‘Please read carefully the precautions before using the device’Approval number of the advertisement:
- Must be clearly indicated in the advertisement
For further information on the above topic, please contact us.
The revised law establishes strict standards and measures in supervision over the whole process of the pharmaceutical industry chain
On 01.07.2019, the 2018 Drug Review Annual Report was released. Of the grand sum of 9,796 registration applications reviewed and approved in 2018, 7,988 were subject to technical review and 1,808 to direct administrative approval.
On 25.06.2019, the NMPA announced the requirements for overseas new drugs, which are urgently needed. The guidelines serve to speed up the drug approval.
On June 29, 2019, the NMPA minister Jiao Hong attended a press briefing on the implementation a strict administration law over vaccines.
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