This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions.Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. This guideline merely demonstrates an appropriate write-up format for acquired data. However, applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration.

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The term combination product includes:

  •  A product comprised of two or more regulated components, i.e., drug/device, biological/device, or drug/device/biological, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
  • Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products.

This guideline describes the following points;

  1. Registration Process
  2. Dossier Requirement
  3. Timeline for Registration of Combination Products
  4. Fees for Registration of Combination Products
  5. Changes/Variation to Particulars of a Registered Combination Product
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This is a ‘Guidance Note’ for applicant/ Marketing Authorization Holder (MAH) who wishes to register the product with the National Pharmaceutical Control Bureau (NPCB).
The applicant/Marketing Authorization Holder (MAH) must ensure the product has fulfilled the definition of product which is under control of the Drug Control Authority (DCA), in order to be registrable with NPCB.

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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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Good Clinical Practice is a set of guidelines for biomedical studies that encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects.

The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented.

The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and the authenticity of biomedical data generated.

This guideline having seven parts:

  1. Definitions
  2. Pre-requisites for the study
  3. Responsibilities
  4. Record Keeping and Data Handling
  5. Quality Assurance
  6. Statistics
  7. Special Concerns
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Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices for their with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017. In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, hereby classify the medical devices and in vitro diagnostic medical devices, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule. The component and accessories to a medical device or companion in vitro diagnostic medical devices has been classified separately.

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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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