HSA releases New Initiatives for Registration of Therapeutic Products- Aug 2021
As part of HSA’s ongoing efforts to enhance clarity in regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry, the HSA has introduced an online self-guided tool for post-approval minor variations application and a DMF acknowledgment email and guidance on deficiency matters.
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.
Anvisa will begin monitoring prices of medical devices
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Anvisa signs agreement with European Medicines Agency (EMA)
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Guideline for Importation Process of Vaccines in Brazil
Material organized by Procomex brings description about the vaccine importation process into Brazil.
The US FDA Announces OTC Monograph Drug User Fee Rates for FY2021
On December 28, 2020 , the U.S. Food and Drug Administration ( FDA) announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2021.
Brazil’s Anvisa defines requirements for requests for emergency use of vaccines
A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.
Mexico’s Cofepris Modifies Pharmacovigilance Regulation: NOM 220-SSA1-2016
On October 30 2020, Mexico’s COFEPRIS, modifies NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.
Brazil’s Anvisa is approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S
Brazil’s ANVISA has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative.
Registration Of COVID-19 Rapid Tests with Brazil’s Anvisa- Required Documents
Anvisa published the Resolution (RDC 348/2020) to speed up the evaluation of new products for detection of the new coronavirus (SARSCoV-2). Check out GRP’s blog on all the required documents necessary to register COVID-19 rapid tests with Brazil’s Anvisa.
Australia’s TGA GMP inspections during COVID-19
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.