European Medicines Agency (‘EMA’) publishes new electronic submission format of information on medicine.

Pharmaceutical companies will soon have to submit information on medicines which are authorised or registered in the EU in a new electronic format recently published by the EMA.
The EMA has advised pharma companies to familiarise themselves with the new submission requirements before electronic submission begins this month and will be providing instructions on how to conform with the new format, together with a data-entry tool to assist small and medium-sized firms.
Companies must submit the required data to the EMA by 2 July 2012. The purpose of the new initiative is to create a list of all medicines authorised and registered in the EU, to identify medicines accurately and to strengthen the EU safety monitoring system for medicines.

Irish Medicines Board (‘IMB’) recalls Nurofen Plus tablets.

The IMB has implemented a precautionary recall of all packs of Nurofen Plus from Irish wholesalers after the discovery of rogue blisters of anti-psychotic and epilepsy drugs in packets of the well-known painkiller in the UK and Northern Ireland.

The distribution of Nurofen Plus has been stopped in the UK and Ireland and the incident is being investigated by the UK police.

FDA seeks two more months for drug review.

The American Food and Drug Administration (the ‘FDA’) is seeking an extra 60 days to be added to the timeline for its review of prescription drugs, in addition to the current 10-month waiting time for standard reviews or six months for priority reviews.

The proposal was part of a proposed five-year agreement with the prescription drugs industry in relation to the fees paid by drug-makers to the FDA for drug reviews. It is proposed that the review clock will begin at the conclusion of 60 days after the receipt of the drug review submission from the drug company.

European Directorate for the Quality of Medicines & Healthcare (‘EDQM’) publishes report on use of membrane systems for production of water for injections (‘WFI’).

The EDQM has recommended initiating discussions regarding the use of membrane systems for the production of WFI. Currently in Europe, the production of WFI must be performed by distillation only, while in Japan, both distillation and membrane techniques are permitted. Previously, concerns had been raised as to the microbiological quality of the water produced by membrane systems.

Recent surveys by industry bodies confirmed that the quality of the water produced by properly operated and designed membrane systems had improved greatly. The report stated that new production methods would be required to deal with contaminants and ensure acceptable product safety levels.

Contributed by Carol Plunkett.