Pharmaceuticals 13th September 2023 4 min read

One of the most regulated industries in the world is the pharmaceutical one, and rightly so. Regulatory bodies are there to ensure safety and compliance within the areas of development, production, and distribution.

The quality and security of Active Pharmaceutical Ingredients (APIs) are crucial to ensure medication is safe and effective. The pharmaceutical sector has regulations in place to make sure that every player in the industry upholds strict standards to guarantee patient safety. We talk with IMCD’s Head of API Technical Support and Business Development Manager, Anne-Claire Bizet, about global issues and how our teams are focused on staying on top of any changes.

What is the purpose of regulatory bodies?

Anne-Claire: The target of any regulatory body in any country is always the same. It is to provide patients with safe, efficient, and high-quality drug products. This goes for both authorities and all stakeholders involved in the API and finished dosage form production including manufacturers, distributors, and wholesalers.  

How does IMCD support our partners when new regulations are announced?

Anne-Claire: Having a broad network within IMCD, our country teams can support and keep up with local regulations. We provide our customers with technical and regulatory support for APIs both prior to registration and in the post-approval stage. We support them in getting the required documentation from manufacturers, but also assist our manufacturers when they need it, as regulations are different in every country. Some manufacturers may be very aware of the regulations in big regions like the US or the European Union, but sometimes they need more assistance in countries with less experience in international dealings. In these cases, we thoroughly explain the registration needs or even support with document improvements as per specific requirements. Of course, we are monitoring the evolution of regulations, so that when there is something new coming, we are ready to answer any questions that may arise.  

This has been the case with the new Certificate(s) of Suitability (CEP 2.0), for which the transition period started on June 1st, 2023. The EDQM (European Directorate for Quality of Medicine & Healthcare) already disclosed the changes and gave examples. This will have an enormous impact on all our customers in Europe and all countries where CEP is recognised, as well as on most of our API suppliers worldwide. As such, we are closely following the situation and we are ready to support our partners, especially during the transition period and beyond. 

What are the most significant changes that CEP 2.0 will bring? 

Anne-Claire: EDQM already published valuable information and started a series of virtual meetings. These webinars are not only crucial for us, but for all stakeholders (CEP holders, drug product manufacturers, regulatory agencies, and end customers). EDQM is trying to make the CEP 2.0 easier and more appealing for global users. New applications and revisions from the 1st of June will result in ‘new-look’ CEPs or hybrid CEPs. Some of the most significant changes will be the following: 

 - More transparent CEP system for authorities and users 
 - A new online public certification database providing more information regarding history of changes 
 - Authorities database with restricted access and list of authorities having access available on EDQM website 
 - Electronic document with digital signature and LOA (Letter of Access) system 
 - Numbering system and layout will change whilst remaining similar to what we are used to with improvements and clarifications 
 - Reduction in number of CEP revisions (no revision if there is no change in the original document) 

There are many different benefits resulting from the CEP 2.0 for all stakeholders, from manufacturers to end customers. One clear advantage, alongside simplicity, is the CEP holders’ increased level of responsibility towards end customers. EDQM is reinforcing the message that CEP holders must share more information with customers, and not stop at the CEP only. This type of information can be linked to stability or even hot topics like nitrosamine impurities. Our strength as a distributor is that we have a wide network of technical and regulatory API experts, and we are monitoring the current situation locally and globally to answer all stakeholders; from API manufacturers to the end customers related to these global changes. 

Are there any recent examples of regulatory changes? 

Anne-Claire: One example would be in Brazil, with the recent CADIFA process (letter of suitability of the active pharmaceutical ingredient). The Brazilian authority has moved the industry from a low-regulated market to a highly regulated market in just a few years. Our colleagues from IMCD Brazil have had to adapt very promptly to support their customers and their manufacturers to be able to answer the expectations of authorities, again in quite a short period of time. The speed in which we act is important, as delays will occur before we are able to come to commercial sales. If an active ingredient is not fully registered, our customers cannot purchase it. It is the responsibility of the technical and regulatory team to provide any possible support to our customers and to our manufacturers so that the product can be launched in the market. 

The IMCD team is fully committed to staying updated on the latest developments in legislation and regulations affecting APIs and excipients. Our team is ready to help our partners at every stage.  

Contact us to find out more