International Conference on Harmonization. Report on the research work "Development of the Concept for ensuring the quality of medicines in the Russian Federation

creating a forum for constructive dialogue between regulators and the pharmaceutical industry in terms of current and objective differences in registration requirements in the US, EU and Japan in order to ensure faster introduction of new medical products into practice and access to patients; participation in public health protection from international perspectives; monitoring and updating harmonized technical requirements leading to greater mutual recognition of R&D data; avoiding different requirements in the future by harmonizing selected areas necessary for further development of therapy and new technologies for the production of medical products; ensuring the dissemination and understanding of harmonized guidelines and campaigns that update or replace current regulations and allow more economical use of human and material resources without compromising safety; ensuring the dissemination and understanding of harmonized of these guidelines, their use for the implementation and consolidation of common standards.

From the European Union, the European Medical Devices Agency (EMEA) and the European Federation of Pharmaceutical Manufacturers and Associations (EFPIA) participate in the work of ICH. From the USA, the ICH includes the Food and Drug Administration (FDA) of the USA and the Association of Pharmaceutical Developers and Manufacturers of the USA (PhRMA). From Japan, the Medicines Agency and medical devices The Ministries of Health, Labor and Social Affairs of Japan and the National Institute of Health Sciences, and the Japan Pharmaceutical Manufacturers Association (JPMA).

safety

efficiency

quality

The introduction of uniform standards at the international level is a rather long process, especially if these standards relate to complex processes. Nevertheless, the harmonization of regulatory requirements in the pharmaceutical sector at the global level is gaining momentum. At the root of this trend lies the ever-increasing degree of globalization of the pharmaceutical industry itself. In addition to improving efficiency, regulatory harmonization should ultimately ensure that quality medicines are widely available to all those who need them, no matter where they are geographically.

At present, the harmonization process is still far from an acceptable level. This leads to significant losses of time and money in the pharmaceutical industry. For example, according to a survey by the European Federation of Pharmaceutical Industries and Associations (EFPIA), in some cases the cost of preparing dossiers for new drug can amount to 15-20% of the cost of clinical trials, in which hundreds of millions of dollars are invested. The study showed that there are a large number of inspection organizations, partly unnecessary, that require hundreds of thousands of dollars a day to operate. Indeed, from 1000 to 2500 man-hours are spent on the inspection of one production. Harmonization of approaches to the preparation of dossiers, the introduction of uniform standards for the inspection of production facilities would help to avoid unnecessary costs in the pharmaceutical sector as a whole and direct the saved resources to solving the necessary tasks. (Europe Today)

Significant progress has been made over the past five years in the area of ​​standardization of R&D and clinical trial requirements, as well as harmonization of regulatory requirements for finished products. dosage forms, active pharmaceutical ingredients (APIs) and excipients.

The main driving force behind regulatory harmonization in the pharmaceutical sector is the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). For 21 years now, ICH has been committed to eliminating redundant documentation and simplifying the process of developing, manufacturing and registering pharmaceuticals. The ICH is made up of regulators, pharmacopoeias, and drug manufacturers from the US, Japan, and Europe. This organization has developed general approach to the problem of harmonization and set priorities for the implementation of this complex and multilateral project.

In addition to the ICH, a number of other organizations are involved in the harmonization of regulatory requirements in the pharmaceutical sector, for example, the US Committee (US Pharmacopeias Discussion Group). The World Health Organization is also involved in the harmonization process, as is the Pan American Society for the Harmonization of Drug Regulation. Other groups involved in the harmonization of regulatory requirements in different countries have concentrated their efforts on individual problems in the field of active pharmaceutical ingredients and excipients.

Some progress in harmonization

An example is the progress made by the United States and European countries in harmonizing regulatory requirements in the pharmaceutical sectors of these countries. By applying the ICH recommendations on quality standards and using a common format for technical documentation, the US and Europe have come up with a single dossier form for a number of drugs.

Japan, which was moving along the path of national standards five years ago, is now showing significant interest in cooperation in the direction of harmonization of regulatory requirements in pharmaceuticals.

Perhaps the most significant symbol of harmonization progress made in the 21st century is the single electronic form of technical documentation that companies use to prepare registration dossiers. As a joke, they now recall the time when it was necessary to take a truck to deliver the entire volume of registration dossier documents to the regulatory authorities.

In the field of harmonization of standards for the production of pharmaceuticals, the process currently underway is a direct reflection of the reality of the supply of most APIs to the US and European countries from India and China. Two years ago, the Food and Drug Administration and the United States (USP) opened offices in China, India and Latin America. The presence of representative offices and USPs directly in the producing countries has improved their interaction with local regulatory authorities, manufacturers and pharmacopoeias.

Progress in Harmonization of Pharmacopoeias, APIs and Excipients

Harmonization of Pharmacopoeias began about 10 years ago. Over time, good cooperation has been established between the US, Japanese and European Pharmacopoeias. However, harmonization in this area is a long and extremely laborious process. For example, the US Patent Documentation Group (USP's PDG) has only worked out 27 out of 34 general statements and 40 out of 63 excipient monographs so far.

Attempts are being made to harmonize monographs up to finished drugs.

At the global level, harmonization of the quality parameters of APIs and excipients is one of the key issues. It is planned that the USA will contain monographs on all pharmaceutical excipients according to the list. This will create an international working group dissemination of best practices. European Quality Directorate medical preparations(The European Directorate for the Quality of Medicines & HealthCare - EDQM) has established bilateral relations with the US FDA and its equivalent agency in Australia
(Australia’s Therapeutic Goods Administration – TGA) on the exchange of confidential information on APIs and excipients. As part of these agreements, as a pilot project, mutual inspections began last year.

Several possibilities are being considered for global harmonization of quality parameters for excipients. One of them is the application of requirements for the production of excipients; the other is the participation of manufacturers in a voluntary program of inspection of production facilities by independent auditors. The International Pharmaceutical Excipients Auditing is registering with the American national institute standards, allowing it to serve as an independent quality auditor.

Remaining Differences

Harmonization does not mean a literal repetition of all procedures for the registration of pharmaceutical products. There will always be differences in the approaches taken by different regulatory agencies. Even within the framework of one European Union, a new one can be registered “centrally”, i.e. through EU authorities, or go through registration with national agencies. The US FDA's strategy is to harmonize the safety requirements for pharmaceuticals in the US and the EU, although some differences in approaches and procedures will still remain.

National specificity is visible on the example of the inspection of pharmaceutical production. The US FDA, for example, focuses on abnormality investigations, validation rules, and the maintenance and cleanliness of equipment and manufacturing facilities. In the EU countries, the main efforts are focused on the compliance with the cleanliness of the premises and their classification, the maintenance of equipment and laboratory control. In Japan, inspectors place increased demands on the quality of raw materials, the cleanliness of production equipment and appearance finished pharmaceutical preparations.

"Pharmaceutical industry", April No. 2 (19) 2010

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The Eurasian Economic Commission has developed a draft Rule for conducting research on biological medicines in the territory of the Eurasian Economic Union (EAEU). The purpose of the document is to simplify the collection and provision of data attached to applications for registration of biological drugs.

The rules are necessary for the formation of a common drug market in the EAEU, which will start operating from January 1, 2016. From this date, safe, effective and high-quality drugs will be able to move freely throughout the Union.

The draft Rules have been developed on the basis of the provisions set out in the relevant documents of the International Conference on the Harmonization of Technical Requirements for Registration of Medicines (ICH) and the European Medical Agency (EMA).

The document regulates the development, safety, efficacy and quality studies of both new molecules of biological drugs and biosimilar drugs. At the same time, the Rules have chapters on general research issues: from banks that produce cells to finished drugs. There is a separate chapter that contains drug-specific requirements for the development, production and research of biosimilar drugs.

Strict adherence to the Rules will help pharmaceutical manufacturers to complete the full cycle of studying biological products, confirm their safety, quality and effectiveness, ensuring that the reproduced biomolecules correspond to their prototypes. This will allow you to replace medications given their comparable safety and efficacy.

It should be noted that the Rules are mandatory for the authorized bodies and expert organizations when performing the procedure for assessing the safety, quality and effectiveness of this group of drugs in the process of evaluating their registration dossiers.

A high degree of harmonization of the Rules with the requirements of relevant international documents will facilitate the process of entering the named drugs on foreign markets, will facilitate the recognition of data on pharmaceutical development and the results of confirmation of safety, quality and efficacy during their registration outside the Union.

The draft decision of the EEC Council on the approval of the Rules for conducting trials of biological medicines in the territory of the Eurasian Economic Union is published on the websites of the Eurasian Economic Union in the section "Public Discussions and ODS" and the Eurasian Economic Commission on the page of the Department of Technical Regulation and Accreditation of the EEC in the section "Public discussion of draft regulatory legal acts".

All interested parties may, within 30 days from the date of publication of the draft document, submit comments to the EEC Department for Technical Regulation and Accreditation.

Reference

To biological medicines include immunobiological and biotechnological drugs, drugs derived from human blood plasma, probiotics (eubiotics), bacteriophage drugs, high-tech drugs.

International Conference on Harmonization of Technical Requirements for Registration of Medicines (ICH) is an organization that brings together regulatory authorities and the pharmaceutical industry in Europe, Japan and the United States to discuss the scientific and technical aspects of drug registration.

European Medical Agency (EMA) is an EU agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

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