Who does the label regulatory reviews?

Pharmaceutical companies and Contract Research Organisations (CROs) tend to handle IMP / AMP labelling in one of two ways:

In-house
Partner with a specialist label printing company who also handle the regulatory checks.

For either scenario, there is frequently no other option but to outsource the regulatory aspect of IMP / AMP labelling to a third party. More and more Language Services Providers (LSPs) are entering the regulatory area who, in turn, outsource this work to their in-country network. The people who actually do the label review are removed from the pharmaceutical company or CRO by up to four degrees and the end-client has no visibility at all of who is doing this work.

Nonetheless, whoever is undertaking the reviewing stage must keep abreast of all regulatory norms that may impact the labelling of trial products. In an ideal scenario, the service provider must have dedicated resources allocated to monitoring Competent Authorities around the world.

Expertise in Local Regulatory Frameworks

The service provider’s review capability needs to rely on a thorough knowledge of the regulatory environment in each trial country. This is because IMP / AMP labelling guidelines vary significantly from one trial country to another. In general terms, these regulatory frameworks can be categorized as follows:

Countries/regions that have specific legislation/guidance to IMP / AMP labelling requirements, such as the USA, EMA region, Australia, Canada.
Countries that incorporate aspects of IMP / AMP labelling into their general medicinal product labelling legislations
Countries where there is occasionally a discrepancy between the theoretical legislative requirements and what is accepted in practice
Countries with no published legislation or guidance on IMP labelling. These are typically countries that are not well established for the running of clinical studies
Countries with no legislation for any aspect of medicinal product labelling, whether commercial or investigational
Countries with legislation but which is not in the public domain (there really are countries like this!).

Knowing which of these categories a target country falls into allows the service provider of label reviews to adapt carefully its reviewing strategy. A high level of preparedness allows the service provider to offer the client a structured, comprehensive and proactive service that is able to anticipate potential problems. These problems could relate to the translation and localisation of the IMP label text or in the regulatory review aspect. This would avoid costly delays at the start of the trial. The most efficient scenario would be for the service providers to be involved at the beginning of the labelling process, i.e. when IMP labels are first designed. This would mean that the service provider is in the best possible position to advise the trial sponsor on the layout and content strategies that will minimise adaptation work.

The Regulatory Review Process

A thorough regulatory review process should include the following steps:

Using the source label, typically in English, the service provider conducts a systematic and in-depth analysis of the regulatory requirements for each country where the trial will take place. This review should ideally be conducted by in-house regulatory experts.
Once the in-house review is complete, labelling associates who reside in the countries in question will perform a second review to check for any inconsistencies or missing information stemming from the in-house check
Once the service provider is satisfied that the regulatory reviews for each country are complete and accurate, the label translations, editing, desktop publishing and quality assurance steps can then be carried out.

What else should the service provider offer?

To complement this process, the service provider should also develop specialised glossaries for each country to advise a client on how particular phrases, such as ‘keep out of reach of children’ or ‘for clinical trial use only’, as well as expiry date formats can change from country-to-country. The service provider should also notify clients about additional wording required for individual countries that have unique labelling requirements, such as Germany, South Korea, New Zealand, USA and others.

By Mark Gibson, Health Communication Specialist

21st September 2019, United Kingdom

Investigational Medicinal Product labelling: what to look for in a supplier