Regulatory Updates

EMA looks to revise guideline on investigation drug interactions

EMA has proposed to change the agency’s guideline for investigating drug interactions.

EMA states that studying drug interactions is growing more important as the European population ages, with more patients taking multiple drugs simultaneously.

The following items have been identified and would need to be addressed in the revised guideline:

1. New recommendations on:

– Inhibition and induction of enzymes in the intestine: specifying cutoffs for poorly soluble drugs.

Brexit update of CMDh advice on changing RMS

CMDh have updated their procedural advice on changing the Reference Member State in a Mutual Recognition or Decentralised procedure. Changing your RMS is normally only allowed in exceptional circumstances and for a justified reason. In light of Brexit the following paragraph has been added, clarifying that Brexit is seen as a “justified reason”:

MS have furthermore agreed upon that a justified reason is “RMS has triggered Article 50 of the Treaty on European Union”.

Sweden gives companies the option of applying for temporary reimbursement

A new guideline on the pricing and reimbursement of medicines in Sweden, which introduces the concept of “temporary reimbursement”, came into force on 1 April. Companies that are planning to launch a product that will replace a product currently only available on a “special permission on a named patient basis” can now apply for a temporary reimbursement while their reimbursement application is assessed by The Swedish Dental and Pharmaceutical Benefits Agency (TLV). The aim is to ensure that patients that are receiving a product on a named patient basis have continuous access to the product after it is granted a marketing authorisation.

European Commission recommends changes to SmPC and Package Leaflets

The European Commission has released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs.

The Commission states in the report that the EMA should update its guidelines to improve the comprehension and readability of PL and SmPC to safe use of drugs in the EU. Two studies included in the report were aimed at assessing the readability and comprehensibility of the SmPC and PL and to determine whether a “key information section”

MHRA publishes guidance that identifies common issues with clinical trial applications and how to avoid them

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays.

MHRA states that more than half of all applications require additional information to be submitted before they are considered approvable. While MHRA typically reviews clinical trial applications for Phase I studies in around 12 days, and 22 days for other trials,