When the Innovative Licensing and Access Pathway (ILAP) was launched at the start of 2021, it was announced that the Target Development Profile (TDP) will be available to applicants to support their application through this pathway. Read more “Detailed guidance on the Target Development Profile Toolkit”
Category: PV
Keep up to date with the latest pharmacovigilance news in the pharmaceutical and regulatory affairs industry.
CDSCO moves towards online SAE reporting system
India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice informing sponsors that they will soon be required to file Serious Adverse Event (SAE) reports electronically via the Sugam online portal from 14 March. Read more “CDSCO moves towards online SAE reporting system”
What is the Safer Medicines in Pregnancy and Breastfeeding Information Consortium?
This network is formed of 16 organisations from the National Health Service (NHS), regulators, and leading third sector and charitable organisations. The aim of the consortium is to improve the dissemination of information for women who are considering pregnancy, are already pregnant or are breastfeeding. Read more “What is the Safer Medicines in Pregnancy and Breastfeeding Information Consortium?”
EC proposes “HERA Incubator” initiative to pre-empt the threat of COVID-19 variants
The European Commission (EC) has proposed an action plan called the “HERA Incubator” to shape the European Union’s (EU’s) strategy for combating the threat of future COVID-19 variants. The initiative is modelled on the annual influenza vaccine programme. Read more “EC proposes “HERA Incubator” initiative to pre-empt the threat of COVID-19 variants”
MHRA provides guidance on managing COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance document on managing clinical trials during COVID-19 with a new section pertaining to the management of non-COVID-19 trials in the context of the current COVID-19 vaccination programme. Read more “MHRA provides guidance on managing COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials”
FDA releases annual medicine quality report for 2020
The Office of Pharmaceutical Quality (OPQ), a department within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has released a report detailing the efforts it made in 2020 to ensure quality medicines are made available to the public. Read more “FDA releases annual medicine quality report for 2020”
Part 3 of the MHRA’s RSI for clinical trials blog
The Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate blog shares the inspection activities carried out by the agency. A third blog post on Reference Safety Information (RSI) for clinical trials has recently been released covering this aspect of pharmacovigilance. Read more “Part 3 of the MHRA’s RSI for clinical trials blog”
Public consultation on EMA’s revised GVP risk minimisation module
The European Medicines Agency (EMA) has released draft versions of the latest revisions to Module XVI of its good pharmacovigilance practice (GVP) guidelines for public consultation. Read more “Public consultation on EMA’s revised GVP risk minimisation module”
A summary of recent TGA guidance to industry
The Therapeutic Goods Administration (TGA) of Australia has recently released updates to numerous guidance documents for the industry. Read more “A summary of recent TGA guidance to industry”
Detailed guidance on the electronic submission process for applications to the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has detailed the registration process for submitting applications and reports through national portals. Read more “Detailed guidance on the electronic submission process for applications to the UK”