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drug promotion
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drug regulatory authorities
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multisource (generic) products
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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)
Table of Contents
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 authorities
1
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 Commerce
1
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 Interchangeability
1
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 promotion
1
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 sheet
2
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 forms
1
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
Annex 11: *Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
1
1
Also published as Annex 5 of WHO Technical Report Series, No. 863, 1996
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