Anvisa will begin monitoring prices of medical devices
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
How China’s NMPA Monitors Adverse Events due to Vaccines Handling
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.
Anvisa signs agreement with European Medicines Agency (EMA)
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
How China’s NMPA Review Application for Chemical Drug Changes
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.
China’s CDE releases Guidelines for Acceptance and Review of Chemical Drug Changes
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes” with Information on requirements for completing a Chemical Drug Change.
Guideline for Importation Process of Vaccines in Brazil
Material organized by Procomex brings description about the vaccine importation process into Brazil.
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.
Anvisa’s role in monitoring adverse events during immunization – Covid-19
Brazil’s EUA procedure assesses the suitability of Covid-19 vaccines for use during the current public health emergency to minimize.
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.
Japan’s PMDA Remote Inspections
The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
FDA’s AI/ML Action Plan Includes ‘Tailored’ Regulatory Framework for SaMD
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).