Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for Drug Regulatory Authorities - Regulatory Support Series No. 005: ANNEXES: Annex 11: *Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms 1 : Appendix 2: Stability testing: summary sheet

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:: Temas & Palabras clave

· Palabras clave > drug promotion
· Palabras clave > drug regulatory authorities
· Palabras clave > multisource (generic) products
· Palabras clave > pharmaceutical products

Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for Drug Regulatory Authorities - Regulatory Support Series No. 005
(1998; 213 pages)

Índice de contenido

	PREFACE
	I. INTRODUCTION
	II. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
		A. Political will and commitment
		B. Legislation
		C. Accountability
		D. Resources for the marketing authorization function
		E. Fees and cost recovery
		F. Inventory of existing products on the market
		G. Rational selection of products
		H. Special access schemes
		I. Postmarketing activities
	III. OPERATING ACTIVITIES
		A. Transparency
		B. Policies
		C. Administrative procedures
		D. Guidelines for applicants
		E. Model application form
		F. Communication among departments within the DRA
		G. Relationship of evaluators with GMP inspectors
		H. Relationship of evaluators with the quality control laboratories
		I. Functional relationship of the evaluators with the expert advisory body
		J. Relationship of evaluators with the pharmaceutical industry and confidentiality of data
		K. Meetings with applicants
		L. Procedures for appeals
		M. Collaboration with other DRAs
		N. Collaboration with WHO
		O. Use of external experts as evaluators
		P. Timeframes for processing of applications
		Q. Publication of marketing authorization decisions
	IV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
		A. Applicability
		B. Initial decisions on options for premarket evaluation
		C. Evaluation of data on quality
		D. Quality of starting materials
		E. Container labelling
		F. Toxicological, pharmacological and clinical data
		G. Product Information
		H. Interchangeability
	V. ISSUE OF WRITTEN MARKETING AUTHORIZATION
	VI. VARIATIONS
	VII. PERIODIC REVIEWS
	VIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
	GLOSSARY
	ABBREVIATIONS
	REFERENCES
	ANNEXES
		Annex 1: National drug regulatory legislation: guiding principles for small drug regulatory authorities¹
			1. Introduction
			2. Drafting national legislation: points for consideration
			3. Defining the scope of the marketing authorization procedure for medicinal products
			4. Example of a legislative scheme for regulating medicinal products.
				4.1 General considerations
				4.2 Model Legislative text and commentary (in italics)
					I. Administration
					II. Provisional registration/marketing authorization and inventory of medicinal products
					III. Screening of products and issuance of product licences/authorizations
					IV. Other activities requiring authorization/licensing
					V. General provisions
					VI. Interpretation
			Appendix 1. Example of a legislation scheme for registration of pharmacy personnel
			Appendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
			Appendix 3. References and selected bibliography
		Annex 2: *Guidelines for Implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce¹
			1. Provisions and objectives
			2. Eligibility for participation
			3. Requesting a certificate
			4. Issuing a certificate
			5. Notifying and investigating a quality defect
			References
			Appendix 1. Model Certificate of a Pharmaceutical Product
			Appendix 2. Model Statement of Licensing Status of Pharmaceutical Product(s)
			Appendix 3. Model Batch Certificate of a Pharmaceutical Product
			Appendix 4. Glossary and index (not intended to be a formal part of the Scheme).
		Annex 3: *Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability¹
			Introduction
			Glossary
			Part One. Regulatory assessment of interchangeable multisource Pharmaceutical products
				1. General considerations
				2. Multisource products and interchangeability
				3. Technical data for regulatory assessment
				4. Product information and promotion
				5. Collaboration between drug regulatory authorities
				6. Exchange of evaluation reports
			Part Two. Equivalence studies needed for marketing authorization
				7. Documentation of equivalence for marketing authorization
				8. When equivalence studies are not necessary
				9. When equivalence studies are necessary and types of studies required
					In vivo studies
					In vitro studies
			Part Three. Tests for equivalence
				10. Bioequivalence studies in humans
					Subjects
					Design
					Studies of metabolites
					Measurement of individual isomers for chiral drug substance products
					Validation of analytical test methods
					Sample retention
					Statistical analysis and acceptance criteria
					Reporting of results
				11. Pharmacodynamic studies
				12. Clinical trials
				13. In vitro dissolution
			Part Four. In vitro dissolution tests in product development and quality control
			Part Five. Clinically important variations in bioavailability leading to non-approval of the product
			Part Six. Studies needed to support new post-marketing manufacturing conditions
			Part Seven. Choice of reference product
			Authors
			References
			Appendix 1. Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, August 1994)
			Appendix 2. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations
			Appendix 3. Technical aspects of bioequivalence statistics
		Annex 4: Model Guidelines on Conflict of Interest and Model Proforma for a Signed Statement on Conflict of Interest
		Annex 5: Model Contract between a Regulatory Authority and an External Evaluator of Chemistry, Pharmaceutical and Bioavailability Data
		Annex 6: Model Application Form for new Marketing Authorizations, Periodic Reviews and Variations, with Notes to the Applicant
		Annex 7: Detailed Advice on Evaluation of Data by the Drug Regulatory Authority
		Annex 8: Ethical criteria for medicinal drug promotion¹
			Resolution WHA41.17 adopted by the Forty-first World Health Assembly, 13 May 1988
			Introduction
			Objective
			Ethical criteria
			Applicability and implementation of criteria
			Promotion
			Advertising
			Medical representatives
			Free samples of prescription drugs for promotional purposes
			Free samples of non-prescription drugs to the general pubic for promotional purposes
			Symposia and other scientific meetings
			Post-marketing scientific studies, surveillance and dissemination of information
			Packaging and labelling
			Information for patients: package inserts, leaflets and booklets
			Promotion of exported drugs
			Appendix: Sample drug information sheet²
		Annex 9: Model marketing authorization letter
		Annex 10: Model List of Variations (Changes) to Pharmaceutical Aspects of Registered Products which may be made without Prior Approval
		Annex 11: *Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms¹
			General
			Definitions
			1. Stability testing
			2. Intended market
			3. Design of stability studies
			4. Analytical methods
			5. Stability report
			6. Shelf-life and recommended storage conditions
			References
			Official, international and national guidelines
			Appendix 1: Survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs: answer sheet
			Appendix 2: Stability testing: summary sheet

Appendix 2: Stability testing: summary sheet

An example of a form in which the results of stability testing can be presented is shown below. A separate form should be completed for each pharmaceutical preparation tested.

Accelerated/real-time studies

Name of drug product
Manufacturer
Address

Active ingredient (INN)
Dosage form
Packaging

Batch number	Date of manufacture	Expiry date
1..................................	../.../19	../.../19
2..................................	../.../19	../.../19
3..................................	../.../19	../.../19
Shelf-life	... year(s)	....month(s)

Batch size	Type of batch (experimental, pilot plant, production)
1...................................	....................................................................................
2...................................	....................................................................................
3...................................	....................................................................................
Samples tested (per batch) ........

Storage/test conditions:
	Temperature	...°C	Humidity	... %
	Light	...cd

Results

1. Chemical findings

2. Microbiological and biological findings

3. Physical findings

4. Conclusions

Responsible officer..................................................Date .. /.. /19

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