European Commission initiative to revamp pharmaceutical legislation

In November 2020, the European Commission (EC) adopted its Pharmaceutical Strategy for Europe in which one commitment was to conduct a review of its pharmaceutical legislation. The EC has now released a roadmap outlining how it plans to deliver this regulatory overhaul. Read more “European Commission initiative to revamp pharmaceutical legislation”

EMA releases further guidance on the control of nitrosamine impurities in sartans

Following the Committee for Human Medicinal Products (CHMP) Opinion on the presence of N-nitrosamines in sartans, the European Medicines Agency (EMA) has released a Q&A guidance document to aid manufacturers in implementing the CHMP Opinion. Read more “EMA releases further guidance on the control of nitrosamine impurities in sartans”

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”

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”

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”