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.
China’s NMPA Publishes the “Cosmetic Supervision and Administration Regulation”
On June 29,2020 The National Medical Products Administration (NMPA) published a new cosmetic regulation known as the “Cosmetic Supervision and Administration Regulation”.
TGA announces new fee schedule and delays in proposed regulations
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July1, 2020.
China’s NMPA releases new regulation on the Registration of Biologics in China
China’s NMPA releases on June 30,2020, No. 43 of 2020 to regulate biologics efficiently, NMPA has divided biologics into 3 categories.
China’s CMDE releases new procedure for medical device registration
China’s Center for Medical Device Evaluation (CMDE) released 2 announcement revising medical device registration procedures.
China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies
Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers. New Drug Review […]
Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19
The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)
China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .
Singapore’s HSA implements Provisional Authorization Process to Expedite Approval of COVID-19 Diagnostic Tests
Singapore HSA implements provisional authorization process for kits intended to detect and/or diagnosis COVID-19 infection to address the need for COVID-19 diagnostic tests.