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 post COFEPRIS – Statement to the Pharmaceutical Industry on the occasion of the follow-up to the implementation of WHODrug and MedDRA 2024 first appeared on Pharmacovigilance ..read more

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 […] The post HSA-Singapore regulation on Cosmetic products first appeared on Pharmacovigilance ..read more

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 … The post MDCG – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 first appeared on Pharmacovigilance ..read more

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 … The post FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products first appeared on Pharmacovigilance ..read more

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 … The post DSUR Submissions and Fees Update from MHRA first appeared on Pharmacovigilance ..read more

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 … The post CMDh update – Q &A on Pharmacovigilance Legislation first appeared on Pharmacovigilance ..read more

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 … The post Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry first appeared on Pharmacovigilance ..read more

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 … The post Electronic submission of IND safety reports to FDA first appeared on Pharmacovigilance ..read more

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 … The post The CIOMS report – Introduction to MedDRA Labeling Grouping (MLG) first appeared on Pharmacovigilance ..read more

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” reached reached Step 2 of the ICH process on 5 February 2024. The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as … The post ICH E2D Guidelines update first appeared on Pharmacovigilance ..read more