Guidance Delivers Much that’s Expected, but Some Surprises

Written by Andrew Marr, Managing Director, Marr Consultancy Ltd.

The release of the EMA’s EVMPD guidance has given industry much of the clarification it needs for moving forward – some of it expected, but some of it a surprise.

One change that caught the industry by surprise is the requirement to list products that are authorised for use in children. This was not mentioned at the meeting with industry groups or at the Information Day EMA held in the lead up to its guidance release. What is now required is if a product has an indication in children or dosing recommendation for children, then it must be flagged as being authorised for use in children in the comments field. Unfortunately, this is not a dedicated field.

This presents some challenges because companies will have to collect pieces of information as a flag and place text – perhaps with the aid of software – in the comments field, which may already be used for other purposes. In particular, this is additional workload for companies that have already gone through all their product information. Now they have to go through the information again to check whether there is mention of use in children. While it’s easy enough to do, it’s a logistical exercise that potentially forces companies to backtrack on their information search.

While the new guidance offers clarification on many issues, there is one area where that’s not the case. The agency has decided to postpone releasing the life cycle management guidance associated with how to do manage the changes until after a meeting to be scheduled in April or May with trade associations. Technically the infrastructure is there in the specification, but any question or detail around how to do it, timing, etc. has gone unanswered in this guidance and the agency has simply said it will announce this after meeting with trade associations.

The troubling part of this is if a company has any variations or updates to do after they have submitted their data and before 2nd July, that simply won’t be possible at this stage. Therefore, companies need to keep that in mind and not forget a variation or change to update at a later date. There’s always a danger that companies’ change control processes will forget about it.

As such, companies need to put in place their strategies and mechanisms for keeping track of what they have changed and on 2nd or 3rd July or whenever it is, submit the changes once they’ve been told how to by the EMA. There are, however, indications that companies will be able to use the nullify operation for erroneous records. So if they do accidently submit something that’s wrong there’s an operation type they can use that deletes the record. It would seem the EMA has not positively excluded the use of that type of operation.