Pharma GMP News of the Week: 8-January-2023
Period: January 1, 2023 to January 7, 2023
The Central Drugs Standard Control Organization (CDSCO) requested that human vaccination firms submit summaries of their “established” pharmacovigilance systems
Month of News: December 2022
The New Drugs and Clinical Trials Rules, 2019 require each new medication imported or manufactured in India to have a pharmacovigilance system for collecting, processing, and reporting adverse drug reaction data to the central licencing body. The pharmacovigilance system must be administered by skilled and trained employees, and data processing must be overseen by a medical officer or pharmacist trained in collecting and evaluating adverse drug reaction reports.
Indian medical device testing facilities needs to enhance their capacity for evaluation
Month of News: December 2022
CDSCO has issued a request to laboratories that have been accredited by the National Accreditation Board for Testing and Calibration Laboratories and are capability and expertise for performing medical device work under the 2017 Medical Devices Rules (MDR). The FDA is searching for laboratories that meet these criteria in order to submit MDR, 2017 applications.
FDA Published guideline “Format and Content of a REMS Document Guidance for Industry”
Date of news: January 04, 2023
This guideline updates the structure and content of a risk assessment and mitigation strategy (REMS) document for a prescription medication product, including a biological drug product. A REMS document, which is part of a REMS needed by FDA, specifies the REMS’s aims and requirements.
Source: Guidance for Industry: Format and Content of a REMS Document
FDA Published guideline “REMS Document Technical Conformance Guide”
Date of news: January 04, 2023
This Technical Conformance Guide (Guide) for Risk Evaluation and Mitigation Strategy (REMS) Documents provides updated, detailed instructions on the format of a REMS Document, as well as standardised language that describes common REMS requirements for applicants to use whenever possible, to help ensure consistency and facilitate efficient review of the REMS Document. This Guide explains how to submit a REMS Document in Structured Product Labeling (SPL) format. Furthermore, this Guide includes an outline to help applicants create a Bifurcated REMS Document.
