Rare Diseases in China: Approval and Coverage of Orphan Drugs
In December of 2020, the National Security Health Administration has also updated its annual list of drugs that are covered under the Basic Medical Insurance Plan.
Cosmetic Registration and Filing Management of new Cosmetic Materials in China Part II
On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021.
Cosmetic Registration and Filing Management of new Cosmetic Materials in China Part I
On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021.
China’s NMPA Drafts new Regulations on Patent Linkages
China’s Patent Linkage Measures is a draft policy addresses market approval of generic drugs and the patent status of branded equivalents.
China’s CDE Releases guidance for the Technical requirements of Generic injections
China’s CDE releases guidance on the Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections
China’s NMPA announces Delay of Unique Device Identification (UDI) Implementation
Due to the Coronavirus, Chinese Regulatory Authority, National Medical Products administration (NMPA). decided to delay UDI implantation to next year January 2021.
China’s CDE publishes draft for a list of Drugs exempt from BE Studies
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
China’s NMPA Addresses Common Period Risk Evaluation Report (PRER) Issues
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
China’s NMPA resolves issues regarding current administration on drug distribution
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.
Whitening Cosmetics: Regulatory Requirements in China
Freckle and whitening cosmetics are mainly used to reduce skin epidermal pigmentation or help skin whitening and whitening. New regulation have been implement to have ore over site of cosmetic products and prevent serious adverse effects.
China’s NMPA introduces new guidance for COVID-19 drug clinical trials
China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers.
TGA’s expectation on hosting remote inspection during COVID-19 pandemic
Therapeutic Goods Administration (TGA) publishes the Good Manufacturing Practices (GMP) approach for oversees manufacturers to assist manufacturers who may undergo remote inspection.