Regulatory lifecycle management is a major task when your product is approved in multiple countries. You must consider each countries process, regulations and timelines when filing a variation. It is important to understand these complexities to develop an efficient plan of action.

We interviewed our regulatory affairs trainer, Sophie Nageotte, to discuss regulatory lifecycle management for products in global markets. She explains why this is such a big challenge and potential new regulatory changes on the horizon.

 

What are the biggest challenges regulatory professionals face in lifecycle management?

It is true that one of the biggest challenges is managing the regulatory compliance of products that are marketed worldwide. This is because global regulations are not harmonized and so we are faced with various regulations with differences in the regulatory requirements when dealing with post-approval CMC changes. So, when we want to submit a change, we need to consider all the regulations and all the regulatory requirements from around the world.

This leads to a complex situation where the process and requirements differ from country to country.

Example 1
We may need to wait several months before being able to even submit the variation because some countries will require the variation to be approved in other countries first (as a reference).

Example 2
Some countries process the same variation completely differently. It can be a simple notification in some countries whereas others require full approval before you can implement it.

Example 3
The lead time for the evaluation by the regulatory authorities is also very different for the same variation. Some countries vary in time from three months or six months or even 12 months. This means for the same change, you are dealing with timelines of up to one year or two years before being able to implement the change itself. It means you are required to manage the different approval times and the transition period when some countries have approved your change and some have not already.

Overall, it is a very complex situation, very difficult to manage for the companies.

This sounds really complex. What advice would you give to regulatory professionals?

Well, I would say that first they should accept the complexity of the task. Often during my trainings, people ask, how can I do this simply? I always answer. There is no simple way to do it. You must accept the complexity.

So, you have to accept that this will be a long process to gather all the regulatory requirements and regulatory specificities from the countries your product is approved in. You then need to consider all those requirements. It is about accepting that this is complex, and it does take time. There is no simple way to do it.

 

It sounds like the process is very strategic and requires significant planning. Is that correct?

Indeed. Filing variations and implementing variations for products approved in global markets should be managed like projects. They have a defined timeline and there are a lot of people involved in the variations. They also have big impact on the production because it is difficult to anticipate the implementation timeline on the production side. So, yes you must have a strategic planning and to consider these variations like mini projects within the company.

 

And finally, are there any big regulatory changes on the horizon when it comes to variations?

Yes, for Europe, there is a big one coming up. There is this new pharmaceutical strategy initiative that has been started with all the European regulators. It was an outcome from the COVID pandemic. They want to be sure that they can adapt their regulatory pathways to the actual need of the patients. They want also to adapt to new technologies and new ways of developing medicines, such as artificial intelligence.
In the coming two or three years they will evaluate if the current legislation is enough to face all those new challenges or if there is a need to revise the European legislation. The outcome will be a possible revision of the pharmaceutical legislation. There will most certainly be a revision of the guidelines so they are in line with the ICH Q12 guideline.

 

Watch the interview below:

 

Sophie teaches on the following courses:

Understanding EU Regulatory Affairs

 

To view all our regulatory affairs courses follow the link below.

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