Regulatory Guide for Marketing Authorization of
Biological Products, Medical Devices and Diagnostics
Credits: Author: Madhu Smitha Kode
Send any comments to Sarang Kulkarni at sarang@web.venturecenter.co.in.
Version: 1.0
Copyright and rights of usage:
Disclaimer: This website is an information resource on Regulatory Processes for innovators and technology developers in the Biopharma, Medical Devices and Diagnostics field. This is an initiative of NCL Innovations, based on in-house research and compilation focusing on specific market regions namely India, USA and EU.
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Select Regulatory Route |
Where
do you want to Market it? |
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What is your Product? |
United States of America (USA) |
European Union (EU) |
India |
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Biologicals/ Biologics |
Regulatory Body: USFDA Divisions: CBER and CDER Definition: According to USFDA, biological products include a wide range of
products such as vaccines, blood and blood components, allergenics,
somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
Biologics can be composed of sugars, proteins, or nucleic acids or complex
combinations of these substances, or may be living entities such as cells and
tissues. Biologics are isolated from a variety of natural sources —
human, animal, or microorganism — and may be produced by biotechnology
methods and other cutting-edge technologies. [1]. Market Authorization of Biologics in USA |
Regulatory Body: European Medicine Agency (EMA) According to the EMA, a biological medicinal product is a
product, the active substance of which is a biological substance. A
biological substance is a substance that is produced by or extracted from a
biological source and that needs for its characterization and the
determination of its quality a combination of physico-chemical-biological
testing, together with the production process and its control [4]. Market Authorization of Biologics in EU |
Regulatory Body: CDSCO Divisions: DCGI According to DBT, Biologic drugs or biologics (also called as biopharmaceuticals or recombinant therapeutics) refer broadly to substances produced by living cells used in the treatment, diagnosis or prevention of diseases [6]. |
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Medical Device (MD) |
Regulatory Body: USFDA Divisions: CDRH, CBER and OCP Definition: According to USFDA, a medical device is an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is:
i.
recognized in the
official National Formulary, or the United States Pharmacopeia, or any
supplement
to them; or ii.
intended for use in
the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment,
or prevention of disease, in man or other animals; or iii.
intended to affect the
structure or any function of the body of man or other animals, and which does
not achieve its primary intended purposes through chemical action within or
on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of its primary intended purposes [2]. Market Authorization of Medical Devices in USA |
Regulatory Body: European Medicine Agency (EMA) According to the EMA, medical device means any instrument, apparatus, appliance,
material or other article, whether used alone or in combination, including
the software necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of: i.
diagnosis, prevention,
monitoring, treatment or alleviation of disease, ii.
diagnosis, monitoring,
treatment, alleviation or compensation for an injury or handicap, iii.
investigation,
replacement or modification of the anatomy or of a physiological process, iv.
control of conception,
and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may be
assisted in its function by such means [5]; Market Authorization of Medical Devices in EU |
Regulatory Body: CDSCO Divisions: DCGI and Medical Devices Cell According to the Drug and Cosmetics Act (DCA), a medical devices are categorized as a drugs and defined as: “Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board” [7]. |
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In-vitro
Diagnostics (IVD) |
Regulatory Body: USFDA Divisions: CDRH, CBER and OCP According to USFDA, in vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body [3]. Market
Authorization of IVD In USA |
Regulatory Body: European Medicine Agency (EMA) According to the EMA, in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: i. concerning a physiological or pathological state, or ii. concerning a congenital abnormality, or iii. to determine the safety and compatibility with potential recipients, or iv. to monitor therapeutic measures [5]. Market Authorization of IVD in EU |
Regulatory Body: CDSCO Divisions: DCGI and Diagnostics Cell |
References:
[1] http://www.fda.gov/Drugs/informationondrugs/ucm079436.htm#B
[4] Directive 2003/63/EC, Annex 1, Section 3.2.1.1
[5] Directive 98/97/EC, Article 1
[6] Draft guideline for preclinical evaluation of similar biologics in India by DBT, 2011
[7] The Drugs And Cosmetics Act And Rules, Department of Health, Government of India