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”
News
ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations
The regulatory approval of COVID-19 vaccines towards the end of 2020 and start of 2021 coincided with the detection of new SARS-CoV2 strains in the UK, South Africa and Brazil. The ACCESS consortium has released a document detailing the regulatory approach for updating authorised coronavirus vaccines to target new strains. Read more “ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations”
MDCG releases guidance on alternatives to EUDAMED
The European Commission’s (EC) Medical Device Coordination Group (MDCG) has recently issued guidance on harmonised administrative practices and alternative technical solutions to be used until the European database on medical devices (EUDAMED) is fully functional. Read more “MDCG releases guidance on alternatives to EUDAMED”
EMA publishes Version 2 of its Implementation Guide for the submission of data on medicinal products
Standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) are being adopted by the European Medicines Agency (EMA). An Implementation Guide (which the EMA has recently updated to version 2) has been created to help stakeholders prepare for the adoption of these ISO standards. Read more “EMA publishes Version 2 of its Implementation Guide for the submission of data on medicinal products”
Australia’s TGA continues to revamp its medical device regulations
The Australian Therapeutic Goods Administration (TGA) has released more medical device related regulatory guidance as the agency continues to reform its medical device regulations. Read more “Australia’s TGA continues to revamp its medical device regulations”
IMDRF publishes finalised document on IVD device classification
The International Medical Device Regulators Forum (IMDRF) has published a document on the classification of in vitro diagnostic (IVD) medical devices. It has been created with the aim of harmonising the classification of IVD devices in order to ensure a globally consistent approach to premarket approval. Read more “IMDRF publishes finalised document on IVD device classification”
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?”
MHRA updates numerous procedural guidance documents
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated several procedural guidance documents with more detailed information relating to application processes. The changes are summarised below. Read more “MHRA updates numerous procedural guidance documents”
MHRA details pathway for clinical investigations of medical devices
Updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) on clinical investigations of medical devices covers the specifics of the coordinated assessment pathway pilot along with new information on gaining approval.
Read more “MHRA details pathway for clinical investigations of medical devices”
EU regulators outline approach to nitrosamine impurities in human medicines
In September 2019, the European Medicines Agency (EMA) initiated a referral of Article 5(3) of Regulation (EC) No 726/2004 (relating to the authorisation of medicinal products for human use). The EMA has now released a document detailing its approach to implementing the outcome of this referral. Read more “EU regulators outline approach to nitrosamine impurities in human medicines”