Eudravigilance Medicinal Product Dictionary

The Eudravigilance Medicinal Product Dictionary (EVMPD) is a database maintained by the European Medicines Agency (EMA) that contains comprehensive information regarding medicinal products authorised for use in the European Union (EU). The EVMPD is a central repository for product information, including data on active substances, pharmaceutical forms, routes of administration, concentration, and packaging.

The primary objective of the EVMPD is to support EU pharmacovigilance activities. It grants regulatory authorities, such as the EMA and national competent authorities, access to exhaustive and standardised information on medicinal products in order to facilitate surveillance of their safety and efficacy.

The EVMPD enables the identification and monitoring of particular medicinal products throughout their entire lifecycle. It facilitates the accumulation and analysis of safety data, the identification of potential risks, and the implementation of appropriate regulatory actions, such as updating product information, issuing safety notifications, or, if necessary, withdrawing a product from the market.

Manufacturers and proprietors of marketing authorizations are accountable for submitting the necessary data to the EVMPD. The EVMPD information is used for a variety of purposes, including signal detection, risk management, and adverse drug reaction monitoring.

Notably, the EVMPD is continuously evolving, and its requirements and data standards may alter over time to correspond with the most recent regulatory guidelines and technological advancements in Pharmacovigilance.

Significance of Eudravigilance medicinal product dictionary in terms of India

The Eudravigilance Medicinal Product Dictionary (EVMPD) primarily functions as a database for drugs that have been given EU approval for usage. Given that India has its own regulatory body and databases for pharmaceuticals, its relevance to India is limited.

The Central Drugs Standard Control Organisation (CDSCO) in India is the regulatory body in charge of approving, regulating, and overseeing pharmaceutical goods. In order to register products, monitor adverse drug reactions, and conduct pharmacovigilance, the CDSCO maintains its own databases and systems.

Despite the fact that India does not directly apply the EVMPD, it is important to remember that global pharmacovigilance standardisation and collaboration are essential for ensuring patient safety. India participates in international initiatives and communicates with foreign regulatory agencies.

India is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), an organisation that seeks to synchronise pharmaceutical standards throughout the globe. By participating in ICH and other international alliances, India aligns its pharmacovigilance practises with worldwide standards and contributes to the sharing of safety information on drugs.