International experience of the harmonization of registration process for pharmaceuticals for human use

For the first time, the question about harmonization in the field of registration of medicines was raised after the Thalidomide tragedy, which led to the development of a huge number of legislative acts on the assessment of data on safety, quality and efficacy of new drugs.  In this regard, the introduction of the drug to the market of each country has become a very difficult task. The manufacturer needed to collect a huge number of reports corresponding to the legislation of each country. Thus, it was necessary to develop universal requirements for the Common Technical Document (СTD), which would reduce the time and labor required to complete the registration process.

Pioneers in the field of harmonization were the countries of the European Union, which established the common market of pharmaceuticals in 1980. Further in 1990 negotiations were held in Brussels between the European Federation of Pharmaceutical Industry and Associations (EFPIA) and representatives of the US FDA and MHLW of Japan. The result of the meeting was the creation of an organization known by the acronym ICH (The International Council for Harmonization).

 During the first ten years of the work of the Harmonization Council, standards for safety (S standards), quality (Q standards) and efficacy (E standards) of medicines for medical applications were developed. In addition, a Medical Dictionary for regulatory activities has been created. The Harmonization Council has also developed a DTP structure, compliance with which is a prerequisite for the registration of a medicinal product in the EU, Japan and the United States (more about the structure, read in the article “Structure of the general technical document for the state registration of the medicinal product.”).

The process of harmonization of normative documents within ICH includes 5 stages:

  • Coordination of scientific issues of the draft document in joint expert groups, including representatives of the industrial sector and regulatory bodies.
  • Coordination of the draft document with the ICH Management Committee, distribution of the draft document for discussion in regulatory bodies.
  • Discussion of the draft document in the regulatory bodies of the three ICH regions: EU, USA and Japan. Preparation of the final version of the document.
  • The ICH Management Committee adopts the harmonized tripartite Guidelines and recommends them for adoption by the regulatory authorities of participating countries.
  • Harmonized guidelines are officially introduced in each of the ICH regions.

Currently members of ICH are EU countries, Japan, USA, Canada, Brazil, Republic of Korea, Singapore, China. Membership in ICN allows to establish cooperation between member countries in the field of registration of medicines, to exchange information, to participate in training activities.

ICH standards are widely used in practice by Russian companies. For example, ICH Q8 “Pharmaceutical development” has been translated into Russian and contains recommendations for providing the results of pharmaceutical development in the materials of the registration dossier in CTD -format.


  2. ICH Q8 «Фармацевтическая разработка» (ICH Q8 — Pharmaceutical Development) Пер. с англ. — К.: Виалек, 2008. — 44 с.
    А.В.Александров, Н.В.Дьшька, В.А.Жулинский, Н.В.Карпенко


©Beawire – May 2019.