ICH - Instilling ‘harmony’ for 30 years, and never more relevant than today!

The year 2020 marks a significant global regulatory anniversary. Thirty years ago, in 1990, the ICH - International Council for Harmonisation - held its inaugural meeting right here in Brussels, Belgium. In fact, EFPIA had the honor of hosting this first meeting of global regulatory authorities and industry experts who were intent on paving the way for better aligned regulatory processes.

Whether I buy my medicine in Brussels, Brasilia or Bogotá, I would like my medicine to be safe, effective and of a high quality. Harmonisation of requirements for drug development and manufacturing will contribute to the objective of safe, effective medicines of high quality all over the world. Thus, the work of ICH has a direct positive effect on patients.

Over the years, ICH has evolved, guiding towards a more expansive reach and a greater depth of convergence. The number of represented countries and regions has considerably expanded from the initial three to now around 50 medicine authorities from across the world that participate as members or observers. When ICH was formed, there were but a handful of approved biological products. Supported by the ICH-driven changes, today, there are novel therapeutic options for previously untreated conditions and hundreds of biological medicines available around the world.

Notably, though, the foundational raison d'être for ICH has remained unchanged. That is to progress increased consistency or harmonisation of global regulatory standards. Aptly, the Oxford English dictionary defines the word ‘harmony’ as “a state of peaceful existence and agreement”. There is probably no better term than harmony to describe the long list of ICH’s accomplishments over the last three decades.

The ultimate success of medicine development is very much reliant on the rules, regulations, and guidelines viewed in concert across the many regulatory agencies and departments of health. In instances where requirements diverge or are redundant across geographies, it may result in increases in medicine development timelines, which impacts access to innovative medicines for patients and global public health. ICH has allowed for collegial exchange of ideas aimed at advancing alignment. Of course, there is often healthy exchange of diverse perspectives. However, ICH has encouraged greater collaboration among scientific, technical and medical experts from regulators and companies. It has helped mitigate confusion regarding regulatory processes. ICH has reduced redundancy in requirements at every step of medicine development: in non-clinical studies, clinical trials, submissions, and manufacturing processes. If that isn’t greater ‘harmony’, then I am not sure what is?

One concrete example of successful harmonization is the electronic Common Technical Document (e-CTD), which has made it possible for companies to submit marketing authorization applications simultaneously in Europe, US and Japan.

Another good example is the fact that both EU and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have implemented ICH quality standards. Thus there is no need for MHRA to align with EU quality standards, which will facilitate discussions for a future mutual recognition agreement between EU and UK on GMP inspections.

ICH influences most R&D functions within EFPIA’s member companies, and therefore, many of the medicines that are available to EU patients today. In fact, ICH exchange has resulted in over 80 collective guidelines. This is an exceptional opportunity for global regulations to keep pace by setting guidelines that address state-of-the-art science in novel fields of development. There are around 30 active working groups progressing the next wave of advances in regulatory standards. Knowing the innovations that are in sight over the next few years, ICH’s mission has never been more important to ensure the availability of life-changing medicines to patients worldwide.

The advances enabled by ICH – truly unprecedented in the history of international medicine regulation – have impacted regulatory practices around the world. Here’s to 30 plus more years of advancing cooperation through ICH…and, here’s to continued regulatory harmony!

Pär Tellner

Pär Tellner is Director of Regulatory, Drug development and Manufacturing at EFPIA since 2012. He is also a  Member...
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