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 PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.
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.
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.
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.
Anvisa instituted the Pilot Program to Expand the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products classes III and IV in the country.
On October of 2020, The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance document called, MDSAP AU P0002.005 Audit Approach.
Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.
The United States Food and Drug Administration lifts halt on domestic routine surveillance facility inspections from week of July 20, 2020.
Therapeutic Goods Administration (TGA) publishes the Good Manufacturing Practices (GMP) approach for oversees manufacturers to assist manufacturers who may undergo remote inspection.
On April 23, 2020, China’s NMPA issued the revised Standard for Quality Control of Drug Clinical Trials (No. 57 of 2020) and will be implemented on July 1.