Drug Regulatory Authorities

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Drug Regulatory Authorities


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DRUG REGULATORY AUTHORITIES Seminar submitted during I M.Pharmacy (Pharmaceutics) I  Semester Course By J.Keerthi Priya , B.Pharm Under the supervision of P.Prem Kumar , M.Pharm Sr.Lecturer. March– 2012 SIMS college of pharmacy, Mangaldas Nagar, Guntur.


INTRODUCTION Relatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals veterinary medicines, medical devices, pesticides, agrochemicals and cosmetics. Ensure that medical products are of acceptable quality safety and efficacy, are manufactures and distributed in ways which ensure their quality until they reach the patient/consumer and their commercial promotion is accurate. The regulations are applied to all drugs from new innovative to long established products. It also applies to drugs from different sources, regardless of whether they are produced domestically or imported by the public or private sector. 9/4/2012 SIMS college of pharmacy 2

Responsibilities of regulatory affairs professionals:

Responsibilities of regulatory affairs professionals Submission of applications to government- For the purpose of examination , test, analysis. For grant of permission to import or manufacture of a new drug or to undertake clinical trail, For conducting bioavailability and bioequivalence study, For registration of products, For certificate of incorporation tracking of licenses etc ., Supporting clinical research trails with review if regulatory document prior to study start up . Providing regulatory strategic direction to the clinical team. 9/4/2012 SIMS college of pharmacy 3

Responsibilities of regulatory affairs professionals:

Preparing and reviewing the scientific technical reports for regulatory adequacy and compliance with appropriate regulatory bodies to ensure timely initiation of clinical studies and market release. Submitting the clinical trail reports to regulatory bodies. Reporting serious adverse events happening during the clinical trails. Obtaining the permission , approval , license from the regulatory authorities. 9/4/2012 SIMS college of pharmacy 4 Responsibilities of regulatory affairs professionals

Responsibilities of regulatory affairs professionals:

Responsible for providing regulatory support to marketed drugs to ensure compliance, which includes reviewing, proposed product labels specifications and method. Supervising the preparation of marketing authorization applications for new pharmaceutical products. Keeping the company management up to date on status of specific products registration actions, problems and solutions. Gaining a rapid and successful approval and maintaining drugs on the market. 9/4/2012 SIMS college of pharmacy 5 Responsibilities of regulatory affairs professionals

Need for regulatory affairs:

Need for regulatory affairs Drugs meant for improving public health and in that sense they are different from any other consumer goods. Their development, manufacture, importation, subsequent handling within the distribution chain and use requires specialized knowledge and skills. They should conform to prescribed standards and their quality should be controlled rigorously. Experience has shown that poor regulation of drugs can lead to the release of substandard, counterfeit, harmful and ineffective drugs to national and international markets resulting in serious harm to the health of consumers. 9/4/2012 SIMS college of pharmacy 6

Drug regulatory authorities:

Drug regulatory authorities The specific interests of regulatory agencies vary from nation to nation depending on the country’s socio-economic situation. Goals are generally the same. Different organizations are working in different countries as drug regulatory authorities at the national and international level. The scope, nature and practice of drug regulation, including priorities, standards, norms, enforcement strategies and resources available from country to country. 9/4/2012 SIMS college of pharmacy 7

Agencies of united states of America:

Agencies of united states of America The P an A merican Health Organization (PAHO) PAHO is an international public health agency with hundred years of experience. Serves as the specialized organization for health of the inter American system Serves as the regional office for the A merican world health Organization International recognition as part of the United Nations System. Food and Drug Administration (FDA) Agency of the united states department of health human services. Led by a commissioner of food and drugs, appointed by the president with the advice and consent of senate. Responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, ERED, cosmetics etc., 9/4/2012 SIMS college of pharmacy 8

PowerPoint Presentation:

It is divided into 7 main divisions or centers :- Office of regulatory affairs Canter for biologics evaluation and research Center for drug evaluation and research Center for devices and radiological health Office of combination products Team biologics Pharmaceutical inspectorate 9/4/2012 SIMS college of pharmacy 9

Agencies of United Kingdom:

National Institutes for Biological Standards and Control (NIBSC): Multi-disciplinary scientific establishment. safeguard and enhance public health by standardizing and controlling biological substances used in medicines. Agencies of United K ingdom 9/4/2012 SIMS college of pharmacy 10

Agencies of United Kingdom:

Medicines and Healthcare Products Regulatory Agency (MHRA): Primary objective is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety , quality and efficacy. Regulation of medicines and medical devices and equipment used in healthcare, and the investigation of harmful incidents. Agencies of United K ingdom Executive agency of the department of health with trading fund status . 9/4/2012 SIMS college of pharmacy 11

Agency of India:

Agency of I ndia Central drugs standard control organization (CDSO): Largely works on developing standards and regulatory measures for drugs, diagnostics and medical devices. Headed by Drug Control General of India. Located at N ew Delhi , functions under the Directorate General of Health Services. ZONAL OFFICES OF CDSO EAST ZONE: Andaman and N icobar Island, Arunachal Pradesh, Assam, Bihar, Jharkhand, Manipur, Meghalaya, Mizoram, Nagaland, Orissa, S ikkim, Tripura & West Bengal. 9/4/2012 SIMS college of pharmacy 12


ZONAL OFFICES OF CDSO WEST ZONE: Chhattisgarh , Goa , Daman & Diu , Gujarat, Madhya P radesh and Maharashtra Sub zonal office: Ahmedabad NORTH ZONE : Haryana, Himachal Pradesh, Jammu and Kashmir, Punjab, Rajasthan, Uttaranchal, Uttar Pradesh, N.C.T of Delhi & union territory of Chandigarh. SOUTH ZONE: Andhra Pradesh, Karnataka, Kerala, Pondicherry and Tamil Nadu. Sub zonal office: Hyderabad Agency of India 9/4/2012 SIMS college of pharmacy 13

Functions of CDSDC:

Functions of CDSDC Laying down standards of drugs, cosmetics, diagnostics and devices. Laying down regulatory measures amendments to acts and rules. To regulate market authorization of new drugs. To regulate clinical research in I ndia. To approve licenses to manufacture certain categories of drugs as central license approving authority i.e., for blood banks large volume parenterals and vaccines and sera. To regulate the standards of imported drugs. Testing of drugs by central drug labs. Publication of Indian pharmacopoeia. 9/4/2012 SIMS college of pharmacy 14

Functions of CDSDC:

Coordinating the activities of the state drugs control organizations to achieve uniform administration of act and policy guidance . Participation in the WHO GMP certification scheme . Conducting the activities of the regulatory officials & Govt. analysts . Distribution of quotas of narcotic drugs for use in medicinal formulations . Screening of drug formulations available in Indian market. Evaluation / screening of applications for granting No Objection Certificates for export of unapproved / banned drugs . 9/4/2012 SIMS college of pharmacy 15 Functions of CDSDC


THE WORLD HEALTH ORGANIZATION 9/4/2012 SIMS college of pharmacy 16 A specialized agency of the UN that act as a coordinating authority on international public health . Objective: Attainment of the highest possible level of health by all people . Approves the WHO program and the budget. Provides government and pharmaceutical manufacturers with the means to establish and maintain mechanisms, which measures quality, safety and efficacy of pharmaceutical products and their rational use. Quality assurance of pharmaceuticals , prevention of counterfeit drugs , drug safety, support to drug regulatory authorities and monitoring of narcotic and psychotic substances.

Role of WHO in Drug Regulation:

Role of WHO in Drug Regulation Regulates in fourfold.. First : Issuing necessary norms and standards through its expert Committees. Second : implementation of drug regulation on national level and its harmonization on regional and global level. Third : selecting areas of essential products , ensuring the quality , safety and efficacy of limited high public health value essential medicines and vaccines. Fourth : facilitates exchange of regulatory information for which it has developed a number of tools. 9/4/2012 SIMS college of pharmacy 17

Other Agencies :

Other Agencies Country Drug Regulatory Authority Australia The therapeutic Goods Administration Canada The Health Products and Food Branch China The State Food and Drug Administration South Africa The Medicines Control Council Colombia The instituto Nacional de Vigilance de Medicamentosy Alimentos Ireland Irish Medicinal Board Brazil Brazilian National Health Vigilance Agency japan Pharmaceuticals and Medicinal devices Evaluation Centre Saudi Arabia Saudi Food and Drug Authority 9/4/2012 SIMS college of pharmacy 18

Reference :

Reference Drug regulatory affairs by Sai kishore Theory and practice of industrial pharmacy by LEON LACHMAN HERBERT A. LIEBERMAN JOSEPH L. KANIG 3 RD edition 9/4/2012 SIMS college of pharmacy 19

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9/4/2012 SIMS college of pharmacy 20 Any query

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