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A significant part of the quality of a finished product is dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper system of qualification of suppliers is necessary to ensure a constant sourcing of APIs of appropriate quality and to safeguard the public health interests. This will be done through standardized quality assessment and inspection procedures. The National Pharmaceutical Control Bureau (NPCB) under the purview of the Ministry of Health Malaysia has introduced mandatory control of APIs as part of the requirements in the product registration application.

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The requirements for pharmaceutical and analytical information are divided into ten parts in the application form. A Pharmaceutical Expert Report (PER) or summary of all the information / Quality Overall Summary (QOS) may be included in PART 2C.

The parts are as follows:
1. PART 2A Pharmaceutical and biological availability
2. PART 3A Active pharmaceutical ingredient (API) Biological medicine primary production lot/batch
3. PART 3B Formulation
4. PART 3C Specifications and control procedures for pharmaceutical ingredients
5. PART 3D Containers and packaging materials
6. PART 3E Manufacturing procedure
7. PART 3F Final product specifications and control
8. PART 3G Stability data of the finished pharmaceutical product (FPP)
9. PART 3H Pharmaceutical development
10. PART 3I Expertise and premises used for the manufacture of a biological medicine

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The registration of medicine in South Africa is governed by the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965, (hereafter ‘the Act’) and the Regulations and Guidelines published in terms thereof. These Guidelines describe the information required for the registration of “medicines” and for an application to amend a registered medicine. The information submitted will be evaluated in terms of the
provisions of the Act.

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 Guidelines are meant to guide the applicant in meeting the requirements of the Act. It is acknowledged, however, that in some instances scientific developments may dictate alternative approaches. When a deviation from a guideline is decided on, a detailed motivation giving the reason(s) for the deviation and justification for the alternative approach should be included in the expert report submitted with the application.

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This document is a summary of questions that relate to the South African guideline, validation criteria and specification documents (i.e. 2.21 South African Specification for eCTD Regional – Module1, 2.22 South African eCTD validation criteria and guideline 2.23 Submission in eCTD format) and represents Medicines Control Council’s current view. It is intended to be a dynamic document that supplements and actualises the above-mentioned guideline documents. The document will be updated as the guideline documents undergo change
control or as new questions are submitted to the Authority.

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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. GCP provides assurance for trial subjects’ safety and data integrity. It is of utmost importance that this standard is upheld at all times. In so doing, all those who are involved in clinical trials will provide the assurance that the rights, safety and well-being of the study subjects are safeguarded; in keeping with the principles that have their origin in the Declaration of Helsinki.

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This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained.  It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.

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The National Pharmaceutical Control Bureau (NPCB) has the responsibility for the inspections and investigations in all clinical trials pertaining to medicinal products for human use. Following the decision made by Ministry of Health on the National Medicines Policy, there should be an established requirement for compliance with Good Clinical Practice for all clinical studies pertaining to medicinal products for human use to determine whether the clinical studies were conducted in accordance with applicable regulatory requirements which include regulations, ethical standards, the Malaysian Guidelines for Good Clinical Practice and the Declaration of Helsinki.

The Drug Control Authority (DCA) had endorsed Guideline for Good Clinical Practice inspection in accordance with the regulation 29 under Control of Drugs and Cosmetics Regulation 1984 in the 221 meetings on the 29th October 2009. The Guidelines for Good Clinical Practice Inspection will integrate the principles of GCP as described in the Malaysian Guidelines for Good Clinical Practice, regulations and also to ensure that the clinical trials are carried out in accordance with the ethical principles that are reflected, for example, in the Declaration of Helsinki. This may include but may not be limited to conducting clinical trials in accordance with the approved protocol, that the data generated are accurate; that subjects enrolled in clinical trials are not subjected to undue risks and that the trial is conducted in accordance with the generally accepted principles of GCP.

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This document specifies Module 1 of the electronic Common Technical Document (eCTD) for South Africa (“ZA”). eCTD is the only valid format for electronic-only submissions to the South African Regulatory Authority. The document should be read in conjunction with the ICH eCTD Specification to prepare a valid eCTD submission for South Africa. The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, life cycle management and archiving of the electronic submission.

The eCTD specification lists the criteria that will make an electronic submission technically valid. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory authority.

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This guideline is issued by DPS under regulation 29, CDCR 1984. This guideline is to be seen in connection with the legal requirements of the CDCR 1984, Sale of Drugs Act 1952 and Poisons (Psychotropic Substances) Regulations 1989. Under the regulation 7(1), CDCR 1984, except as otherwise provided in these Regulations,no person shall manufacture, sell, supply, import or possess or administer any product unless the product is a registered product and the person holds the appropriate licence required and issued under these Regulations.

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