Official, international and national guidelines. Appendix 1. Appendix 2. Stability testing: summary sheet. Multisource generic pharmaceutical products: guidelines on registration requirements to establish interchangeability 1. Part One. Regulatory assessment of interchangeable multisource pharmaceutical products. Multisource products and interchangeability.
Technical data for regulatory assessment. Product information and promotion. Collaboration between drug regulatory authorities. Exchange of evaluation reports. Part Two. Equivalence studies needed for marketing authorization. Documentation of equivalence for marketing authorization. When equivalence studies are not necessary. When equivalence studies are necessary and types of studies required.
Part Three. Tests for equivalence. Bioequivalence studies in humans. Pharmacodynamic studies. Clinical trials. 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. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations. Appendix 3.
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Technical aspects of bioequivalence statistics. Quality assurance in pharmaceutical supply systems 1. Introduction and general considerations. Elements of quality assessment and assurance. Pre-marketing quality assessment. Drug quality surveillance during marketing. Guidance for those preparing or commenting on monographs for preparations to be included in The international pharmacopoeia 1.
Compendia of World's Medicinal Flora
Validation of analytical procedures used in the examination of pharmaceutical materials 1. General guidelines for the establishment, maintenance, and distribution of chemical reference substances 1. Criteria for determining the need for the establishment of chemical reference substances. Evaluation of reference substances. Chemical and physical methods used in evaluating reference substances. Handling and distribution of reference substances. Reference materials calibrated against International Chemical Reference Substances.
Means of promoting effective exchange of information and ensuring cooperation between organizations establishing reference substances. General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis 1. List of available International Chemical Reference Substances 1. List of available International Infrared Reference Spectra 1. Collaboration within the basic test programme 1. National laboratories for drug quality surveillance and control 1. First-stage laboratory for drug surveillance.
Medium-size drug control laboratory. Scope of activity.
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Factors influencing the size and location of a laboratory. Implementation of control laboratory projects. Good laboratory practices in governmental drug control laboratories 1. Management and operational issues. Sampling procedure for industrially manufactured pharmaceuticals 1. General precautions to be taken during sampling operations. Packaging and labelling of samples. Sampling during pharmaceutical inspections.
Sampling of pharmaceutical dosage forms in regular surveillance programmes on drug quality during marketing. Sampling of pharmaceutical dosage forms for acceptance of consignments. Sampling of starting materials.
Provisions and objectives. Eligibility for participation. Requesting a certificate. Duke, J. Rodale Press. Wichtl M ed. In Herbal Drugs and Phyto-pharmaceuticals. CRC Press, Stuttgart, pp. In addition, manufactured herbal medicines often follow in the wake of migrants from countries where traditional medicines play an important role. In both developed and developing countries, consumers and health care providers need to be supplied with up-to-date and authoritative information on the beneficial properties, and possible harmful effects, of all herbal medicines.
The Fourth International Conference of Drug Regulatory Authorities, held in Tokyo in , organized a workshop on the regulation of herbal medicines moving in international commerce. Another workshop on the same subject was held as part of the Fifth International Conference of Drug Regulatory Authorities, held in Paris in Both workshops confined their considerations to the commercial exploitation of traditional medicines through over-the-counter labelled products.
The Paris meeting concluded that the World Health Organization should consider preparing model guidelines containing basic elements of legislation designed to assist those countries wishing to develop appropriate legislation and registration. As a general rule in this assessment, traditional experience means that long-term use as well as the medical, historical and ethnological background of those products shall be taken into account. The definition of long-term use may vary according to the country but should be at least several decades.
Marketing authorizations for similar products should be taken into account. Prolonged and apparently uneventful use of a substance usually offers testimony of its safety. In a few instances, however, investigation of the potential toxicity of naturally occurring substances widely used as ingredients in these preparations has revealed previously unsuspected potential for systematic toxicity, carcinogenicity and teratogenicity. Regulatory authorities need to be quickly and reliably informed of these findings.
They should also have the authority to respond promptly to such alerts, either by withdrawing or varying the licences of registered products containing suspect substances, or by rescheduling the substances to limit their use to medical prescription. This should cover all important aspects of the quality assessment of herbal medicines. It should be sufficient to make reference to a pharmacopoeial monograph if one exists. If no such monograph is available, a monograph must be supplied and should be set out as in an official pharmacopoeia.
The botanical definition, including genus, species and authority, should be given to ensure correct identification of a plant. A definition and description of the part of the plant from which the medicine is made e. The active and characteristic constituents should be specified and, if possible content limits should be defined. Foreign matter, impurities and microbial content should be defined or limited.
Voucher specimens, representing each lot of plant material processed, should be authenticated by a qualified botanist and should be stored for at least a year period. A lot number should be assigned and this should appear on the product label. Plant preparations include comminuted or powdered plant materials, extracts, tinctures, fatty or essential oils, expressed juices and preparations whose production involves fractionation, purification or concentration.
The manufacturing procedure should be described in detail. If other substances are added during manufacture in order to adjust the plant preparation to a certain level of active or characteristic constituents or for any other purpose, the added substances should be mentioned in the manufacturing procedures. A method for identification and, where possible, assay of the plant preparation should be added.
If identification of an active principle is not possible, it should be sufficient to identify a characteristic substance or mixture of substances e. The manufacturing procedure and formula, including the amount of excipients, should be described in detail. A finished product specification should be defined.
A method of identification and, where possible, quantification of the plant material in the finished product should be defined. If the identification of an active principle is not possible, it should be sufficient to identify a characteristic substance or mixture of substances e.
The finished product should comply with general requirements for particular dosage forms. For imported finished products, confirmation of the regulatory status in the country of origin should be required. The physical and chemical stability of the product in the container in which it is to be marketed should be tested under defined storage conditions and the shelf-life should be established.
This should cover all relevant aspects of the safety assessment of a medicinal product. A guiding principle should be that, if the product has been traditionally used without demonstrated harm, no specific restrictive regulatory action should be undertaken unless new evidence demands a revised risk - benefit assessment.
A review of the relevant literature should be provided with original articles or references to the original articles. However, although long-term use without any evidence of risk may indicate that a medicine is harmless, it is not always certain how far one can rely solely on long-term usage to provide assurance of innocuity in the light of concern expressed in recent years over the long-term hazards of some herbal medicines.
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Toxicological studies, if available, should be part of the assessment. Literature should be indicated as above. As a basic rule, documentation of a long period of use should be taken into consideration when assessing safety. This means that, when there are no detailed toxicological studies, documented experience of long-term use without evidence of safety problems should form the basis of the risk assessment. However, even in cases of drugs used over a long period, chronic toxicological risks may have occurred but may not have been recognized.
The period of use, the health disorders treated, the number of users and the countries with experience should be specified. If a toxicological risk is known, toxicity data must be submitted. The assessment of risk, whether independent of dose or related to dose, should be documented. In the latter case, the dosage specification must be an important part of the risk assessment. An explanation of the risks should be given, if possible. Potential for misuse, abuse or dependence must be documented.
If long-term traditional use cannot be documented or there are doubts on safety, toxicity data should be submitted. This should cover all important aspects of efficacy assessment. A review of the relevant literature should be carried out and copies provided of the original articles or proper references made to them. Research studies, if they exist, should be taken into account. The pharmacological and clinical effects of the active ingredients and, if known, their constituents with therapeutic activity should be specified or described.
The indication s for the use of the medicine should be specified. In the case of traditional medicines, the requirements for proof of efficacy should depend on the kind of indication. For treatment of minor disorders and for non-specific indications, some relaxation in requirements for proof of efficacy may be justified, taking into account the extent of traditional use.
The same considerations may apply to prophylactic use. Individual experiences recorded in reports from physicians, traditional health practitioners or treated patients should be taken into account. Where traditional use has not been established, appropriate clinical evidence should be required. As many herbal remedies consist of a combination of several active ingredients, and as experience of the use of traditional remedies is often based on combination products, assessment should differentiate between old and new combination products.
Identical requirements for the assessment of old and new combinations would result in inappropriate assessment of certain traditional medicines. In the case of traditionally used combination products, the documentation of traditional use such as classical texts of Ayurveda, traditional Chinese medicine, Unani, Siddha and experience may serve as evidence.
An explanation of a new combination of well known substances, including effective dose ranges and compatibility, should be required in addition to the documentation of traditional knowledge of each single ingredient. Each active ingredient must contribute to the efficacy of the medicine.
Clinical studies may be required to justify the efficacy of a new ingredient and its positive effect on the total combination. Product labels and package inserts should be understandable to the consumer or patient. The package information should include all necessary information on the proper use of the product. Identification of the active ingredient s by the Latin botanical name, in addition to the common name in the language of preference of the national regulatory authority, is recommended.
Sometimes not all information that is ideally required may be available, so drug regulatory authorities should determine their minimal requirements.
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