Proceedings of the Eighth International Conference of Drug Regulatory Authorities (ICDRA) - Bahrain, 10-13 November 1996: The challenge of biotechnology: Regulatory experience In countries with an evolving biotechnology industry

Proceedings of the Eighth International Conference of Drug Regulatory Authorities (ICDRA) - Bahrain, 10-13 November 1996
(1996; 111 pages)

Table of Contents

	Opening ceremony
		Welcome speech by His Excellency Dr Faisal Al-Mousawi, Minister of Health, State of Bahrain
		Opening speech by Dr Hiroshi Nakajima, Director-General, World Health Organization
		Address by Dr Hussein A. Gezairy, Regional Director, WHO Eastern Mediterranean Region
	International harmonization of regulatory requirements Plenary: 10 November 1996
		Introduction - Dr S. Nightingale, United States of America
	Global harmonization
		WHO and regulatory harmonization for pharmaceuticals - Dr. Idänpään-Heikkilä, WHO
	Tripartite harmonization - International Conference on Harmonization (ICH)
		Structure and working methods of the International Conference on Harmonization (ICH) - Margaret Cone, International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
		Statement from ICH 3 - Dr O. Doi, Japan
		Viewpoint of an industry representative from a non-ICH country: quality - Professor Mamdouh A. Razik Moustafa, Egypt
		Viewpoint of a regulator from a non-ICH country: safety - Professor L. Rägo, Estonia
		Progress report from the ICH working group on efficacy - Professor C. Naito, Japan
		ICH efficacy documents - a non-ICH country view - Dr J. McEwen, Australia
	Regional harmonization activities
		The new European marketing authorization system - Mr F. Sauer, European Agency for the Evaluation of Medicinal Products (EMEA)
		Regional harmonization in the Americas - Dr E. Fefer, WHO/AMRO
	Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
		The implications of the TRIPS agreement for the protection of pharmaceutical Inventions - Adrian Otten, World Trade Organization
		Effect of WTO agreements on pharmaceutical trade in Arab countries - Mr M. Jafar Redha, Bahrain
		Closing remarks - Dr S. Nightingale, United States of America
		Recommendations
	The mission of drug regulatory authorities
		The importance of the mission - Dr A.W. Broekmans, Netherlands
		Regulatory control In a changing environment - Dr E. Fefer, WHO/AMRO
		Financing of a drug regulatory authority and user fees - Ms Layla Abdul-Rahman, Bahrain
		Structure and financing of a drug regulatory authority - Dr T. Tominaga, Japan
		Structure and financing of a drug regulatory authority - Dr M.N. Dauramanzi, Zimbabwe
		Discussion group conclusions
		Recommendations
	Counterfeit drugs
		Combating counterfeiters - Dr K. Jones, United Kingdom
		Counterfeit medicines: a special case for concern - Margaret Cone, IFPMA
		Country studies on counterfeit drugs - Mr Eshetu Wondemagegnehu, DAP/WHO
		WHO guidelines to combat counterfeit drugs - Professor T. Paal, Hungary
		Rapid detection of counterfeit drags using simple tests - Dr S. Mizuno, Japan
		WHO data base on counterfeit medicines - Dr K. Kimura, WHO
		Recommendations
	Computer-assisted drug registration
		Introduction - Professor A. Toumi, Tunisia
		Description of the software package - Dr V. Reggi, WHO
		Country experience in computerized registration - Dr E. Kriel, South Africa
		Country experience in computerized registration - Mr B.K. Khakurel, Nepal
		Country experience in computerized registration - Professor A. Quintana, Venezuela
		Recommendations
	Updates
		Use and future of the International Pharmacopoeia - Professor T. Paal, Hungary
		Drug donations: the Eritrean experience - Kidane Woldeyesus
		Report on diethylene glycol poisoning in Haiti - Dr E. Fefer, WHO/AMRO
		Regulatory measures to allow timely provision of controlled medicines in emergency situations - Mr T. Yoshida, WHO
		Recommendation
	The challenge of biotechnology
		Introduction - Dr E. Griffiths, WHO
		Regulatory experience in countries with an evolving biotechnology industry - Dr C. Sanchez, Cuba
		Regulatory experience In countries with an evolving biotechnology industry - Dr T. Bektimirov, Russia
		Regulatory experience in Importing countries - Dr Mahmood Dada, Saudi Arabia
		Regulatory experience In Importing countries - Dr B. Njue, Kenya
		Regional initiative for vaccine quality assurance - Dr A. Saleh, WHO/EMRO
		Current quality control Issues: cell substrates used for the production of biologicals - Dr T. Hayakawa, Japan
		Recommendations
	Pharmacovigilance
		Introduction - Dr M. ten Ham, WHO
		Monitoring of adverse drug reactions - Professor E. Gabrielian, Armenia
		Monitoring of adverse drug reactions - Dr J. McEwen, Australia
		Monitoring of adverse drug reactions - Dr P. Folb, South Africa
		Monitoring of adverse drug reactions - Dr E. Kkolos, Cyprus
		Recommendations
	WHO Certification scheme: current developments
		How to improve implementation of the Scheme in a developed country - Mr H. Smallenbroek, Netherlands
		Certification of pharmaceutical substances - Mr H. Ikäläinen, Finland - Chairman of Pharmaceutical Inspection Convention (PIC)
	Regulatory control and assessment of herbal medicines
		WHO'S activities - Dr X. Zhang, WHO
		WHO monographs on selected medicinal plants - Dr Konstantin Keller, Germany
		Herbal medicines: country situation - Mr A. Chan, Hong Kong
		Herbal medicines: country situation - Mrs Tan Shook Fong, Singapore
		Recommendations
	Registration requirements for multisource products (generics)
		Use of standardized marketing authorization - Professor A. Hildebrandt, Germany
		Requirements for dissolution tests and need for in vivo bioequivalence studies - Dr R. Williams, United States of America
		Evaluation and registration requirements for individual multisource (generic) pharmaceutical products - E.C.M. Santero, Philippines
		Recommendations
	List of participants

Regulatory experience In countries with an evolving biotechnology industry - Dr T. Bektimirov, Russia

According to rules established in the Russian Federation, new vaccines intended for routine clinical use should not be of a lesser quality than similar products already approved by the national control laboratory, the L.A. Tarassevich State Research Institute for the Standardization and Control of Medical Biological Preparations.

Vaccine quality specifications must be established during the preclinical and clinical trial stages of development and cover a range of parameters. Data concerning all substances used in the production process, purification of vaccine antigen and formulation should also be provided. Substances used in the production of a vaccine must be approved by the Pharmacological Committee of the Russian Federation or the developer should present data showing the lack of toxicity of the substances in question.

Details of all elements which may affect the result of control tests are also expected, as well as of the tests themselves. This would include baseline data on the characteristics of animals, details of the experimental techniques and methods of statistical data processing. The reliability of measuring devices and the quality of reagents and other materials should also be monitored.

For licensing, the developer submits a license submission document to the National Control Laboratory. This describes the general characteristics of the preparation and methods for its quality control. It also contains the results of preclinical or clinical testing. Evaluation is carried out by the L.A. Tarassevich State Research Institute and by the Commission on Medical Immunobiological Preparations, Disinfectants and Cosmetics. The Tarassevich State Research Institute submits its report to the Commission which in turn makes recommendations to the Pharmacopoeial Committee of the Ministry of Health of the Russian Federation which takes the final decision.

Clinical trials may be carried out by the developer only when approved by the Scientific Council of the Tarassevich State Research Institute and the Commission. In addition, state (filed) trials are also carried out but only after approval of the report on pilot trials in limited groups. State trials are carried out by independent specialists who did not participate in the development, nor previous clinical trials, of the preparation.

The former USSR and later the Russian Federation, has been self-sufficient in vaccines and most biologicals. Although great attention was paid to quality control and quality assurance conditions by the National Control Authorities, shortage of funding over many years means that many facilities now require modernization and equipment needs upgrading.

Much of the regulatory framework already in place for traditional biologicals will apply to the development and licensing of biotechnology-derived medicines. The main challenges biotechnology production for Russia are the following.

1. Upgrading of quality assurance measures by reconstruction and renovation of establishments and facilities in order to fully meet modern GMP requirements.

2. Introduction of new automated and computerized equipment.

3. Recruitment of highly-qualified engineers for maintaining production and control of equipment.

4. Development of new Russian regulatory documents to strengthen the National Control Authorities.

5. Application of strict penalties to manufacturers violating laws and regulations involved with the production and distribution of biologicals.

6. Modernization of facilities and upgrading of equipment at the Tarassevich Institute for Standardization and Control of Medical Biological Preparations to enable it to carry out the task of assuring the quality of biologicals in the Russian Federation.

Russian experience in regulatory activities has shown that the requirements, standards, reference materials and other publications of the Biologicals Unit of WHO are extremely helpful to the national control authorities. Personnel involved in the standardization and control of biologicals greatly appreciate the assistance provided by WHO through its Biologicals Unit and look forward to continued future collaboration.

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