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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation Drug Registration
China Provisionally Extends Deadlines for Submitting Drug Registration Applications' Supplemental Documents On Oct. 14, 2022, China National Medical Products Administration (NMPA) announced it would temporarily extend the deadlines for drug registration applicants to submit supplemental documents. If finding applications deficient, NMPA will issue deficiency letters that require relevant applicants to submit supplemental documents.
Oct 19, 2022
REGULATION
Law & Regulation Clinical Trial Post-market OTC Drug
China Updates Documentation Requirements for Rx-to-OTC Switch Applications China no longer requires drug quality and efficacy research documents for Rx-to-OTC switch applications. Besides, China gives more detailed specifications under each required document item.
Oct 10, 2022
REGULATION
Law & Regulation Guideline Pharmacopoeia Reference Listed Drug (RLD) GMP Clinical Trial NRDL Health Insurance Generic Drug OTC Drug Cancer
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022 Find out the latest pharmaceutical regulatory updates in China: 1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide; 2. China NMPA Grants One Rx-to-OTC Switch; 3. China NMPA Releases 183 RLDs; 4. China CFDI Consults on Inspection Guidance for Blood Products; 5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL; 6. China CDE Releases Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline
Oct 03, 2022
REGULATION
Packaging
Shanghai Issues the First Drug Packaging Reduction Guideline in China Shanghai, China, is going to implement the guideline to reduce excessive pharmaceutical packaging for capsules and tablets from Sept. 30, 2022.
Sep 28, 2022
REGULATION
Marketing Approval Clinical Trial New Drug US Real World Data
How to Submit Documents with Real-World Data to FDA To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.
Sep 21, 2022
REGULATION
Law & Regulation Guideline Pharmacopoeia Reference Listed Drug (RLD) Clinical Trial Bioequivalence (BE) Generic Drug New Drug COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022 Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
REGULATION
Law & Regulation Pharmacopoeia CMC Clinical Trial API Gene Therapy New Drug
Understanding 42 Guidelines in the Chinese Pharmacopoeia The Chinese Pharmacopoeia 2020 Edition includes 361 general chapters, including 38 general requirements for preparations, 281 testing methods and other general chapters, and 42 guidelines.
Aug 30, 2022
REGULATION
GMP Post-market Volume-based Procurement
China Suspends UCB's Antiepileptic Drug, Keppra, from Import, Sale, and Use On Aug. 24, China NMPA suspended the import, sale, and use of UCB Pharma S.A.’s Levetiracetam Concentrated Solution for Injection (Keppra), a drug for epilepsy treatment.
Aug 26, 2022
REGULATION
Law & Regulation GMP CMC US
CMC: FDA Publishes Guideline With Questions on Post-approval Modification of Single-use Materials With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).
Aug 19, 2022
REGULATION
Pharmacovigilance UK
UK Changes SUSAR Reporting for IMPs The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.
Aug 16, 2022
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