ALL ABOUT PHARMACOVIGILANCE

On 23 April 2024, Cofepris released notification related to the implementation plan of WHODrug and MedDRA as coding standards in Pharmacovigilance. As per the notification, as of January 1, 2024, it is required that the holders of health records and their legal representatives, distributors/marketers, as well as institutions or establishments where health research is carried…

The Health Sciences Authority (HSA) Singapore had released a new Guidance for Reporting of Adverse Effects, Products Defects and Product Recalls for Cosmetic Products in Dec 2023. The guidance provides information to the cosmetics industry on the reporting of adverse effects, product defects and product recalls of cosmetic products to HSA required under the Health…

Medical Device Coordination Group (MDCG) released a document on 15 April 2024 as per Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. This document defines SAE reporting modalities and includes a summary tabulation reporting format. The…

On 11 April 2024, FDA released Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products. This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center…

On April 3, 2024, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”. The draft guidance was published as a response to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary…

The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless MAH provide proof of payment of the DSUR Review Fee with submission. The payment associated…

The Coordination group for Mutual recognition and Decentralised procedures (CMDh) released an update of the CMDh Questions and Answers on Pharmacovigilance Legislation. The Q&A 2 (“How should I submit a new RMP or an updated RMP to update my dossier?”) has been revised to stress that, for RMP updates, a clean and a tracked version…

FDA released guidance on 01-April-2024, that provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs) to FDA Adverse Event Reporting System (FAERS). The electronic submission of the ICSRs from IND-exempt BA/BE studies is a…

FDA is announced the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format:  IND Safety Reports.”  This guidance describes the electronic format, sponsors will be required to use when they electronically submit to the FDA, IND safety reports for serious and unexpected suspected adverse reactions that are required under 21…

The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it is useful for precise coding of adverse events of medicines for data analysis, its high granularity can obscure the communication of adverse reactions in product labeling for healthcare practitioners. Many sponsors and regulators have therefore…