Introduction to Regulatory Affairs

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Brief History
In 1970's Regulatory profession began to emerge as a health related professional. Then in 1980's it recognized internationally and demand for it grew. In 1991, Regulatory Affair Certification (RAC) was introduced.

What is regulatory Affair?

Protection of public health is the fundamental purpose Regulation.
A regulatory affair is a profession which protects the public health by controlling the safety and efficacy of products such as pharmaceuticals, medical devices, veterinary medicines pesticides, agrochemicals, cosmetics and complementary medicines1.
Although protection of public health appears simple goal, it can achieve only through extensive and complex regulation. Safety, Efficacy, Purpose, Risk/benefit and Quality are the core principles on which regulation rely2.

Why Regulatory?

Drug Regulatory Affair Department is the BACKBONE of Pharmaceutical Industry. It is revenue generator for Industry.
The Regulatory Affairs department is an important part of the pharmaceutical companies. Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities.
Regulatory Affairs is involved in the development of new medicinal products, by applying regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.
Regulatory Professional obtains the marketing authorization for the product by presenting the registration document to regulatory agencies, and making the necessary subsequent negotiations.
They contribute in the commercial and scientific success of the product development by giving strategic and technical advice, from the beginning of the product development.
More than 15 years span is required to develop and launch a new pharmaceutical product in the market. During this scientific development many problems may arise.
This process can make fast by avoiding and solving the problem at appropriate steps only with the help of Regulatory Professional. They help the company for keeping proper records, appropriate scientific thinking, update with always changing regulatory guidelines/requirements and proper presentation of data.
Some Important Drug Regulatory Authorities (across the world)
Each and every country has its own regulatory body. Some important authorities among them are mentioned below along with their country name.
1. CDSCO- India
2. USFDA- United States of America
3. EMA-European countries
4. MHRA- United Kingdom
5. Health Canada- Canada
6. TGA- Australia
7. MCC- South Africa
8. ANVISA- Brazil
9. Medsafe- New Zealand
Scope of Regulatory Affair
1. Proper development of the Product.
2. Assuring efficacy, safety, and quality of the product.
3. Review in house documentation & updating other departments.
4. Proper packaging and labeling.
5. Dossier filling/ product submission and getting approval from health agency within specified time period.
6. Making smooth roadways for placing quality product in market.
7. Helping Pharmaco-vigilance of quality/ safety issue post marketing.

What documents Regulatory Professional Prepare?

1. Internal Regulatory Standard Operating Procedure (SOP)
2. New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (INDA) submission documents.
3. Drug Master File (4US type I to V, Canadian, Open and closed part for EU and other market)
4. Dossier for different submission- 5Common Technical Documents (CTD) / Asian CTD (ACTD)/ non-eCTD electronic submission (NeeS)/ 6Electronic CTD (eCTD)/ Country specific dossier.
2. John J. Tobin and Gary WalshMedical Product Regulatory Affairs page no 15
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Author: Aarti Chandak

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