Drug labelling is one of the greatest challenges in clinical trials due to strict regulatory requirements in different countries. George Omburo, VP- Clinical and Product Development at Derma Sciences, advocates for harmonization as a way to save money and time.
CTA: What is the key challenge of clinical trial labelling?
GO: Harmonization in labelling should be something that the regulatory authorities pay attention to. There needs to be a uniform way of labelling drugs that meets all regulatory authorities in the world, particularly in the US, the EU and Japan. We need to go towards harmonization, so when we conduct the same study in the US and Europe, we just need to worry about translation. That is not the case right now. Even within the EU alone you find that one country requires a slightly different way of labelling drugs compared to other countries. That can be a headache to a company that wants to conduct global studies.
CTA: What are the problems of not having a harmonized system?
GO: You lose money and time because each country asks for a unique label. Also, we need people who know the label requirement for each country and the technical requirements. With a harmonized system, we could easily save at least four weeks. This time could be used to conclude studies much sooner. This means drugs would get to the market sooner and reach the patients faster.
CTA: Is the industry doing something about this?
GO: This problem has been identified by the industry, but it has not been brought forward as a big issue to the regulatory authorities yet. Talking about this helps. Usually these issues are driven by the big players and organizations put together panels that discuss these issues. Then the community challenges the regulatory authorities.
CTA: Could web based labels help solve this problem?
GO: No, that only tackles the technological aspect. It does not solve the fact that each country needs labels to be written in a different way and what actually goes onto the label.
CTA: How do you see the future outlook for clinical trial labelling?
GO: A decade ago we did not have a harmonized way of approving drugs. We had to go to each country in Europe to have the drug approved. But I've seen harmonization coming in drug approval. I think the next phase of harmonization will be in global labelling. It should become easier to conduct global clinical trials.
