Masterstudiengang "Drug Regulatory Affairs"

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) started in 1990 with the mission to harmonise technical guidelines and obligations for the development and authorisation of human pharmaceuticals. It has enforced the cooperation of drug regulatory authorities and the pharmaceutical industry of the USA, EU and Japan which constitute the main drug markets in the world.

To evaluate the achievements of ICH over the last 23 years, this work sought to identify its strengths, weaknesses and most important future tasks, based on the feedback from 30 European key opinion leaders (KOLs). The interviewee-panel was selected to encompass representatives of both the pharmaceutical industry and health authorities. The interview consisted of 25 questions addressing the mission of ICH, its guidelines and tools, the harmonisation process, the organisation of ICH and its future tasks. A special focus has been set on determining ways to improve the status quo.

The interviewed KOLs consider ICH to have a positive influence on many fields of drug development and authorisation, namely duplication of clinical trials, animal testing, quality, safety and efficacy of drugs, data presentation, intra-company globalisation and the dialogue between regulatory authorities and the pharmaceutical industry. The positive impact of ICH on the assessment timelines of marketing authorisation applications, time and resources for drug development and patient access to new drugs was considered as debatable. There are no subjects for which ICH was considered to have a negative impact. For these reasons ICH can be regarded as a story of success.

However, the interviewees have identified several subjects requiring amelioration: several ICH guidelines need improvement, various topics demand new guidance, implementation of ICH guidelines should be quicker and more stringent, there should be more cooperation among the health authorities to facilitate harmonisation and new ICH members have to be incorporated while maintaining efficiency.

The interview partners have provided visions and ideas for improving the drug development and authorisation process, overcoming regional differences in the registration dossier, expanding the harmonisation tools of ICH, accelerating the harmonisation process and improving the organization of ICH.

Lastly, the most important future tasks of ICH were pinpointed. It has to (i) generate novel guidelines and improve the existing ones, (ii) outreach to new stakeholders, (iii) further standardise the requirements for drug development and approval, (iv) improve its current structure and organisation and (v) identify and respond to therapeutic advances.

Page number: 86
Annex: 16