This guideline applies to the quality aspects of an application for registration of complementary medicines submitted in ZA-CTD format. Whilst the completed dossier should be checked for completeness, relevance and correctness, for ease of reference, relevant sections (not a complete list) of Module 1 and Module 2 with which information should be congruent/ should correspond, are indicated.
The requirements for the presentation, labelling, copies and relevant procedures for submission of applications, are stipulated in the General and Module 1 guidance.
The Technical Screening form should be completed to assist with checking of the contents before copying and submission.

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In general Complementary Medicines (CMs) are used and sold by many people in RSA. These guidelines accompany the regulations dealing with the registration and post-marketing control of health supplements that are subject to the Medicines and Related Substances Act, 1965 (Act 101 of 1965) – “the Act”. With respect to any registration of a medicine, it is a legal requirement that data submitted for evaluation should substantiate all claims and should meet technical requirements of quality, safety and efficacy of the product for the purposes for which it is intended. The nature of registration of health supplements is such that the MCC wishes to ensure that products sold to the public which fall under this classification are of good quality and are safe. Efficacy of such products is established by the use of permitted claims associated with individual ingredients.

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This document is established to provide guidance for the industry on the reporting of safety information arising from clinical trials requiring the Clinical Trial Import Licence (CTIL) and/or Clinical Trial Exemption (CTX) in Malaysia to the National Pharmaceutical Control Bureau (NPCB), Ministry of Health Malaysia.This guideline will cover the following areas involving safety information reporting.
• Definitions and terminology associated with clinical safety experience
• Standards for expedited reporting
– Elements to be reported
– Reporting time frames
– What, when and how to report
– Managing blinded therapy
• Reporting process in Malaysia
• Documentation requirements for expedited report submission

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The National Pharmaceutical Control Bureau (NPCB) has the responsibility for the inspections and investigations of all BE studies pertaining to medicinal products of human use. This is in accordance to the Directive issued under Regulation 29 of The Control of Drugs and Cosmetics Regulations (CDCR) 1984, Number 1 the Year 2011 on the requirement of Bioequivalence (BE) Study for registration and renewal of all immediate release, oral, solid dosage form generic products. The same Directive also stated the requirements of inspection and accreditation of the BE Centre by NPCB that came into effect since 1 January 2012.

The objectives of BE Centre Inspection are to:

  • Determine the rights, safety and well-being of study subjects have been protected
  • Determine whether the BE study was conducted in accordance with applicable regulatory requirements, ethical standards and Malaysian Guidelines for GCP
  • Determine whether the data submitted in the dossier are credible and accurate
  • Ensure the integrity of scientific testing and study conduct
  • Determine the bioanalytical part of BE study is performed in accordance with the applicable principles of GLP
  • Determine the bioanalytical method used is well characterised, fully validated and documented to yield reliable results that can be satisfactorily interpreted
  • Verify the corrective and preventive actions taken when deemed necessary
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The Complementary Medicines (CMs) that will be the subject to these Guidelines are those associated with those disciplines as determined by Council. Currently six major disciplines have been identified and preparations associated therewith, namely: Homeopathy, Western Herbal Medicine, Traditional Chinese Medicine, Ayurveda, Unani Medicine (Unani-Tibb) and Aromatherapy. In addition, a seventh category – Combination Products – is recognised and dealt with below. The disciplines of CMs are defined in this guideline and evidence required to substantiate the claims made for products falling under any of the disciplines, is divided into high risk or low risk categories. For all CMs, quality and safety are non-negotiable, whereas, depending upon the discipline, proof of absolute efficacy may prove challenging, for a variety of reasons, and therefore concessions have been made in this area for tradition (discipline) based CMs that have a long history of use.

These guidelines accompany the regulations dealing with the registration and post-marketing control of these medicines. The guidelines give some direction with regard to the required information for discipline-specific CMs but should not in themselves be regarded as final. Where an applicant wishes to use and submit information not found in these guidelines, they may do so, but they would have to make thoroughly justified submissions on scientific, technical or traditional grounds.

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Independent Ethics Committee (IEC) is an independent body constituted of medical/scientific and non-medical/scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial. The principles, requirements and standards set out in this document apply to IEC reviewing drug-related clinical trials that relate to areas of responsibility of NPCB. This guideline does not cover for non-drug related clinical trials.

This guideline is intended to provide information regarding the registration of IECs with the National Pharmaceutical Control Bureau (NPCB) which is the secretariat of DCA. This guideline also layout the inspection procedure involved. Under Regulation 30, CDCR 1984, any person who contravenes any directives or guidelines issued by the Director of Pharmaceutical Services commits an offence.

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The Drugs and Cosmetic Acts, 1940 and Rules 1945 passed with the objective of regulating the import, manufacture, sales and distribution and sale of drugs and cosmetics. Acts and Rules are amended from time to time. The main object of the act is to avoid a substandard of drugs in order to maintain a high standard of medical treatment. There are five chapters and two schedules under the Drugs and Cosmetic Act, 1940 and There are nineteen parts and 25 schedules.

Below is the list of five chapters of the act:

  1. Introductory
  2. The drugs technical advisory board, the central drugs laboratory and the drugs consultative committee
  3. Import of drugs and cosmetics
  4. Manufacture, sale and distribution of drugs and cosmetics
  5. Miscellaneous


  1. “Notification for Change in Drugs and Cosmetics Rules, 1945, in rule 96, in sub-rule (1), in clause (i), in sub-clause (A)” attached.
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For this Directive, UV filters are substances which, contained in cosmetic sunscreen products, are specifically intended to filter certain UV rays to protect the skin from certain harmful effects of these rays.

These UV filters may be added to other cosmetic products within the limits and under the conditions laid down in this Annex. Other UV filters used in cosmetic products solely to protect the product against UV rays are not included in this list.

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Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, strontium sulfide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Annex III, Part 1, and of strontium lakes, pigments and salts of the coloring agents listed with the reference (3) in Annex IV, Part 1.

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