• regulations

Alike all other highly regulated industries pharmaceutical industry also has its complicated and always changing regulations. As part of drug development process clinical trials also fall under specific regulations protecting participants safety and well being. 

One of the famous documents that everyone working in clinical research has to read is Good Clinical Practice (GCP). But what is GCP? Is it a regulation or not? The answer is: yes and no. GCP is a quality standard, recommending how to conduct clinical trials involving human beings. Although it is not a regulation itself majority of the countries around the world have incorporated GCP in their local clinical trials regulations. 

Apart from GCP requirements there are numerous local regulations specific for each country. Although it may not look that way for someone not involved in clinical trials but the regulations are very dynamic and there is almost constant changes in processes and procedures on local level. 

Considering the complications described above it is not surprising that regulatory processes and requirements are one of the main challenges for clinical trials teams. All teams find it difficult to stay on top of changing regulations and keep up with their work at the same time. One of the outcomes of this situation is fear of inspections, which results in inefficient communication with regulatory agencies.

Unfortunately some pharmaceutical companies have adopted an easy but not necessarily correct approach: “we don’t know what the regulatory agency want in this case so let’s cover all options”. The result of such approach is that often the solution is worst than the problem. This has negative effect on everyone involved in the process: 

  • Already busy regulatory agencies have to deal with extra amount of submissions and notifications, which may not be even needed.
  • Pharmaceutical companies have to prepare lots of additional documents, which may not be required at all.
  • Clinical trial teams experience increased workload and additional administrative work.

Ironically, the solution to all these complications is a very simple one: communication. Instead of generating additional work for all parties involved, simply ask the regulatory agency for recommendations and advice. All regulatory agencies have helplines and are happy to answer questions and provide recommendations.  

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 2 Feb 2015