Regulatory News from Across Asia-Pacific

NMPA solicits comments on the revised draft of China's medical device classification for sodium hyaluronate products until June 16, 2022.

China cosmetics label requirements have been clarified by the NIFDC for antioxidants, preservatives, stabilizers added as cosmetic ingredients

China NMPA regulations supporting Good Manufacturing Practice (GMP) of drugs in clinical trials will be implemented on July 1, 2022

The 14th Five-Year Plan for Drug Supervision Network Security and Information Construction issued by the NMPA will focus on 16 missions

China cosmetics quality and safety managers must be appointed to meet the CSAR requirements for filing or registration of cosmetics

CSAR China cosmetics infringements are increasing as witnessed recently with the suspension of production of lavender essential oil

Interested in the recommended paths for China medical device clinical evaluation? Contact Cisema regulatory affairs consultancy & CRO

China YY Standards 2022 Implementation and Amendment Plan covers 59 new YY/T standards and 57 existing industry standards to be amended.

"China GMP Medical Device 2022 Edition for sterile and implantable devices" by Beijing MPA replaces the 2016 edition with immediate effect.

Webinar "China Cosmetics Ingredient Code Submission" will be held on June 15, 2022, for cosmetics manufacturers and ingredients suppliers.

The Communication SOP for Medical Device Clinical RWD Applications (Trial) was jointly issued by the CMDE and the Hainan MPA in April 2022.

China clinical application management is an important part of the modern hospital management system to standardize medical technologies.

Cosmoprof Worldwide Bologna 2022 - Schedule an appointment to learn about registration of cosmetics and cosmetic ingredients in China

Measures for the Supervision and Administration of Drug Production was issued by the SAMR and came into effect on July 1, 2020.

Measures for the Administration of Drug Registration took effect on July 1, 2020, to reform the drug review and approval system.

The Guideline for Pharmacovigilance Inspection urge MAHs to implement the main responsibility of pharmacovigilance.

China Drug Annual Reports Administrative Regulations was issued by the National Medical Products Administration on April 12, 2022.

Technical Guideline for Children's Cosmetics sets to standardize and guide the cosmetic product registration/filing to ensure children safety

FAQ for General Cosmetics Filing is a publication first issued by the Beijing Municipal Medical Products Administration in November 2021.

Cosmetics Safety and Technical Standards have been revised by the China National Institutes for Drug Control and currently open for comments.