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Pharmacovigilance principally involves the identification and evaluation of safety signals. Here, safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use.

The main focus of this guideline is to identify the risks, formulate the risk profile of a vaccine and its administration programme, design of appropriate pharmacovigilance plan to mitigate such risks and to explore the missing critical information which did not emerge during premarket phase-I/II/III trials and therefore safety profile had not been established.

This document rationally places guidance that all Marketing Authorization Holder (MAH) of Human vaccines(importers and manufacturers)should establish an appropriate pharmacovigilance system with an adequate number of qualified, trained, experienced manpower to collect, collate all AEFI (minor, severe and serious). This pharmacovigilance system within the company should conduct decisive causality analysis of the collated AEFI cases, after due investigation and prepare case closure report.

In a comprehensive PSUR, all such information shall have to be placed as per the norms stipulated in Schedule-Y of Drugs & Cosmetics Act 1940 and Rules 1945 and submitted to the Licencing Authority i.e DCG(I) in CDSCO (HQ) in a timely manner. CDSCO shall convene the meeting of the PSUR committee within a reasonable time period and give opportunities to the concerned Marketing Authorization Holder (MAH) to present their case and PSUR in general. Based on the recommendation of the PSUR committee the vaccine Licensing Authority i.e. DCG(I) will take appropriate regulatory action in accordance with Drugs & Cosmetics Act 1940 and Rules 1945, so as to monitor the safety and effectiveness of the human vaccine in the market.

MAHs must have a system in place that enhances the overall quality of the receipt, processing and reporting of ADE while ensuring that accurate and complete pharmacovigilance information is provided to CDSCO.

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Throughout the registration validity period of a natural (traditional medicine & homeopathy) and health supplement product, the product registration holder is responsible for the product that is placed in the market and to make any amendments to the registration dossier based on any technical and scientific progress regarding the product. This is required to enable the natural and health supplement products to be manufactured and evaluated by generally accepted scientific methods. Such amendments have to be approved by National Pharmaceutical Control Bureau (NPCB).

This guideline is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a natural and health supplement product of abridged category. It is not applicable for natural and health supplement product of full evaluation category and reference shall be made to Malaysian Variation Guideline for Pharmaceutical Product instead. Variation applications are categorized into Major Variation, Minor Variation (Prior Approval) and Minor Variation (Notification). The guideline covers variation on both drug product (finished product) and drug substance (active ingredient). Updating of this guideline will be done on a periodic basis as required.

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This guidance note is issued specifically for blood establishments in Malaysia and must be read alongside the Guidelines on Site Master File issued by Centre for Compliance and Licensing (CCL), National Pharmaceutical Control Bureau. The reference made to Guidelines on Site Master File should be applicable to the blood establishment settings. A Site Master File should contain adequate information but, as far as possible, not exceed 25-30 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred instead of narratives. The Site Master File, including appendices, should be readable when printed on A4 paper sheets.

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A Similar Biologic product is that which is similar in terms of quality, safety and efficacy to an approved Reference Biological product based on comparability. Similar Biologics can only be developed against the Reference Biologic that has been approved using a complete data package in India. In case the Reference Biologic is not authorized in India, it should have been approved / licensed and marketed in an ICH country.

These guidelines are applicable for Similar Biologics to be developed in India or imported into the country for marketing authorization. These guidelines address the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects for Similar Biologics. These guidelines also address the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for Similar Biologics.

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Distribution is an essential activity in the integrated supply chain management of biological products. Various  individuals and entities are generally responsible for the handling, storage and distribution of such products. So it’s very important to have adequate controls over the entire chain of distribution.

To maintain the original quality of biological products, every party involved in the distribution chain has to comply with the applicable requirement. Each activity in the distribution of biological products shall be carried out according to the principles of Good Distribution Practice (GDP) as applicable (e.g. dry ice, cold pack etc).

These guidelines are intended to be applicable to all persons and outlets involved in any aspect of the storage and distribution of biological products from the premises of the manufacturer of the product to the person dispensing or providing biological products directly to a patient or his or her agent.

This includes all parties involved in trade and distribution of biological, including the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, Government institutions, international procurement organization, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers.

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A biologic product will undergo various manufacturing process changes and updates to their product labelling throughout its lifetime. The changes will be inevitable and are often implemented regularly. Reason of changes would include (but not limited to):
a. To maintain the routine production (e.g replenishment of cell banks, seed lots, and reference standard)
b. To improve the quality attributed or the efficiency of the product (e.g changes in the manufacturing process, equipment of facility)
c. To update product labelling information (e.g to add/edit indication and/or to improve the management of risk by adding a warning, limiting the target population, changing the dosage regimen and adding information on co-administration with other medicinal products)

This document provides guidance for manufacturers and the product registration holders (PRH) on the conditions and supporting documents for a variation application of registered biologic products.

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Distribution is an important activity in the integrated supply-chain management. With the globalization of the pharmaceutical industry, various individuals and organisations from locations around the world are generally responsible for handling, storage and distribution of such products. Therefore it is important to have adequate control over the entire supply chain from manufacture to delivery to the patient or end user. This guideline lays down the appropriate principles for those involved in the supply chain in conducting their activities while ensuring the maintenance of high standards of quality assurance and integrity of the distribution processes. Not all of the principles described will be relevant to every situation as it is recognized not all the principles are applicable to certain companies or environment. The principles should be adapted to meet individual company’s needs where necessary. Alternative practices to those set out in the guideline that achieve an equivalent or better outcome can be adopted by companies provided that such alternative practices can be shown or demonstrated to achieve an outcome that is equivalent to or better than the provisions in the guideline. When the distribution chain is interrupted by manufacturing steps such as repackaging or relabeling, the principles of Good Manufacturing Practice (GMP) should be applied to these processes.

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These rules shall be applicable in respect of; substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant; substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides. All medical devices placed into one of four classes based on the intended use of the device and the potential risk that comes with its use. As per new rules, Notified bodies will audit manufacturing sites and products to ensure conformity to standards. Foreign manufacturing sites may be subject to inspection by India’s Central Licensing Authority.

Note: FAQs related to medical devices and IVDs, and pre-screening checklist also attached.

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