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China GVP: Lifecycle Pharmacovigilance and Patient Safety The China GVP requires the marketing authorization holder (MAH) and sponsor to establish the pharmacovigilance system in an early stage and implement pharmacovigilance activities and a pharmacovigilance quality management system (PV QMS) into their corporate quality management systems (QMS) (China GVP Article 2)
Implementing New GVP in China Requires Digitization and Training For example, China GVP mentions the Pharmacovigilance System Master File and Pharmacovigilance Plan, as part of the marketing authorization holder (MAH) or sponsor obligation to establish a pharmacovigilance system, for the first time in China The China GVP and, for example, the European Medicines Agency GVP are generally similar
Pharmacovigilance: Artificial Intelligence and Global Regulatory . . . The main regulatory reforms involved the Drug Administration Law (DAL) and the Vaccine Administration Law (VAL), two fundamental laws that provide stronger legal protection for public health, and enhancement of the Chinese Good Pharmacovigilance Practice (GVP)
Accession to the EU: How Can the EMA Pre-Accession Assistance Program Help? North Macedonian participants pointed out the usefulness of the topics covered in the Action and noted that the areas of focus, particularly GMP, GCP, and GVP as well as the assessment of generic medicines, met the expectations and needs of their national regulator
Overcoming Various Challenges to Enhancing Risk Communication and . . . 4 Standardization and Consistency in Regulation Updating and standardizing Indian regulations in correlation with other global guidelines like GVP V, GVP XVI, CIOMS Working Group IX, etc , would ensure consistency in risk communication and minimization practices by aligning India with international standards for drug safety and patient protection
Globalizing the Pharmacovigilance System Master File: Challenges and . . . The Implementing Regulation, and in 2012 the EU Good Pharmacovigilance Practices (GVP) Module II guidance, provides a framework allowing a flexible accommodation of the different organizational structures of marketing authorization holders (MAHs)
Patients at the Heart of Middle East Drug Regulation The first DIA pharmacovigilance workshop in the Middle East and North Africa (MENA) Region, presented in parallel with MERC, focused on efforts to simplify and harmonize pharmacovigilance guidelines and announced release of the Algerian GVP (revised version) which came into place in October 2019
July 2021 - DIA Global Forum Article 1 of the China GVP clearly mentions that, “The Practice is formulated in accordance with Drug Administration Law of the People’s Republic of China, Vaccine Administration Law of the People’s Republic of China and other relevant provisions for the purpose of regulating the pharmacovigilance activities throughout the lifecycle of
October 2021 - DIA Global Forum The Implementing Regulation, and in 2012 the EU Good Pharmacovigilance Practices (GVP) Module II guidance, provides a framework allowing a flexible accommodation of the different organizational structures of marketing authorization holders (MAHs)