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 des matières

	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 C. Sanchez, Cuba

As a result of Cuba's interest in the manufacture of biotechnology-derived medicinal products, a group of institutions have been established within the country to provide the technical expertise and support necessary to assure their development. The main centre deals with research, development, and production, while others provide support services and a network for the conduct of preclinical studies and clinical trials.

Eighty-five per cent of biotechnology-derived products on Cuba's domestic market are locally manufactured by the state industry which operates with support from the Center for Genetic Engineering and Biotechnology (CIGB), the Center for Molecular Immunology (CIM) and the Finlay Institute.

The Cuban drug regulatory authority, CECMED, which was created in 1989, is responsible for assuring the quality, safety and efficacy of medicines, including biotechnology-derived medicinal products. CECMED applies national guidelines which have been developed for local industry and cover GMP, GMP for biologicals, GLP, GCP, Good practices for blood banks, and general principles to be followed for process validation. In addition, CECMED provides the following services:

• Inspection of manufacturers;

• Assessment of documentation for registration variations and renewal;

• Issuance of licence certificates for pharmaceutical products; and

• Batch to batch release (documentation, analytical tests or assessment of summarized protocol of batch). CECMED issues the batch release certificates.

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