China NMPA Discloses No. 057 Reference Listed Drug (RLD) List for Public Industry Comments
China’s NMPA announced on March 25, 2022, the issue of the 57th batch of RLD (Reference Listed Drug) for public industry comments.
FDA REMINDS HAND SANITIZER MANUFACTURERS THEY CAN NO LONGER DISTRIBUTE WITH TEMPORARY POLICIES AFTER MARCH 31, 2022
FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (withdrawn on December 31, 2021), they must stop distribution of any remaining hand sanitizer produced consistent with the temporary policies by March 31, 2022.
US-FDA Over-The-Counter Monograph Drug User Fee Program (OMUFA)
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
The USA FDA Issues Guidance on Enforcement Discretion Policies for Certain FSMA Regulations
On March 11, 2022, the U.S. Food and Drug Administration (FDA) issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA).
REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
US-FDA Formal Meetings with OTC Sponsors
Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]
US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA
On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.
The US-FDA Releases White Paper on Testing Methods for Asbestos in Cosmetic Products Containing Talc
On January 13, 2022 , the U.S Food and Drug Administration (FDA) made available the white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics).
NMPA releases a final guidance on Device Master File (DMF) submissions
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
New Rules for Cosmetics Registration in China starting May 2021
The new regulations on cosmetics in china are coming into effect on May 1st, 2021. They include new classification of cosmetic product, new requirements for the ingredients, labeling, safety assessment and animal testing.
Brazil’s Anvisa Certificate of Good Manufacturing Practices
The Certificate of Good Manufacturing Practices is the document issued by Anvisa attesting that a certain establishment complies with Good Manufacturing Practices.
Brazil’s ANVISA outlines reasons for the approval and rejection of registration of synthetic drugs.
Anvisa presents the reasons for the approval and rejection do generic drugs and how companies should proceed in order to register successfully with the Health Authority.