2. INTRODUCTION:
Regulatory authorities act as a guardian that ensures the safety, efficacy
and quality of drugs and medical devices av available to the public.
They work to identify the strengths and weaknesses of drug regulation
and to propose strategies to improve drug regulation.
The international regulatory organizations whether they are
governmental or non-governmental play an essential role in all aspects
of pharmaceutical regulations related to drug product registration,
manufacturing, distribution, price control , marketing, research and
development and intellectual property protection.
3. CDSCO
• The CDSCO (central drugs standard control organisation )
of India is main regulatory body for regulation of
pharmaceutical, medical devices and clinical trails.
• Head office of CDSCO is located in New Delhi and
functioning under the control of Directorate general of
health services, ministry of health and family welfare
government of India.
• DCGI (drug controller general of India ) is responsible for approval of new drugs,
medical devices and clinical trails to be conducted in India.
• DCGI is appointed by the central government, under the DCGI the state drug
control organization will be functioning.
• The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug
Consultative Committee (DCC).
4. Functions of CDSCO in center:
Approval of new drugs and clinical trails.
Import registration and licensing.
Amendment of D&C act and rules.
Testing of drugs by central labs.
Publication of Indian Pharmacopiea.
Monitoring adverse drug reactions.
Banning of drugs and cosmetics.
Grant to license, personal license, NOC’s for export.
Licensing of blood blanks, vaccines, r-DNA products and diagnostic agents.
Participation in WHO GMP certification schemes.
Guidance on technical matters.
5. Functions of state licensing authorities :
Licensing of drug testing laboratories.
Approval of drug formulation for manufacture.
Monitoring of quality of drugs and cosmetics, manufactured by
respective sate and those marketed in the state.
Investigation and prosecution in respect of legal provisions.
Administrative actions.
Pre and post licensing inspection.
Recall of sub standard drugs.
6.
7.
8. FDA
The United States Food and Drug Administration (USFDA) is an agency of the
US department of health and human services (DHHS) that is responsible for the
safety regulation of:
a) most type of foods f) dietary supplements
b) drugs g) biological medical products
c) vaccines h) radiation-emitting devices
d) blood products i) veterinary products
e) medical devices g) cosmetics
The FDA has its headquarters at White oak , Maryland.
9. FDA goals
The food and drug modernization acts states that the FDA has 4 goals
Goal 1 : Strengthen the FDA for today and tomorrow.
Goal 2 : Improve patient and consumer safety.
Goal 3 : Increase access to new medical and food products.
Goal 4 : Improve the quality and safety of manufactured products and the supply chain.
FDA doesn’t regulate :
Advertising (except for prescription drugs, medical devices, tobacco products.
Alcoholic beverages.
Health insurance.
Meat and poultry.
Illegal drugs of abuse such as heroin and marijuana
10.
11. APPLICATION FORMS OF USFDA
1)INVESTIGATIONAL NEW DRUG FORMS (IND)
a) FDA 1571:investigational new drug application
15. 3)ORPHAN DRUG PRODUCTS (for rare diseases and disorders)
There is no form ,but there is a prescribed format for
application for orphan drug status. The section from the regulations that
describes the format can be found in The orphan drug act and related law and
regulation page.
4)ELECTRONIC REGULATORY SUBMISSION AND REVIEW
(ERSR)
Regulation and instructions for submitting drug
application electronic. This web page provides information on CDER’s
program to enable the electronic submission of regulatory information to the
center and the review is done by CDER staff.
16. TGA
The Therapeutic Goods Administration (TGA) is a unit of the Australian
Government Department of Health and Ageing, responsible for administering
the act.
TGA came into effect on 15 February 1991.
TGA head quarters is at Canberra , State of New South Wales, Australia.
17. Role of the TGA :
The TGA carries out an overall control through five main process :
Pre-market evaluation and approval of registered products intended
for supply in Australia.
Development, maintenance and monitoring of the systems for listing
of medicines.
Licensing of manufacturers in accordance with international standards
of GMPs.
Post-marketing monitoring, through sampling , adverse event
reporting, surveillance activities and response to public inquiries.
The assessment of medicines for export.
24. HEALTH CANADA (HPFB)
Drugs are authorized for sale in Canada once they have successfully gone
through the drug review process. This process is the means by which a
drug application is reviewed by scientists in the health products and food
branch (HPFB) of Health Canada, and on occasion, outside experts, to
assess the safety , efficacy, and quality of a drug.
Throughout this process, the safety and well-being of Canadians is the
paramount concern.
Health Canada’s HPFB is the national authority that regulates, evaluates,
and monitors the safety, efficacy and quality of therapeutic and diagnostic
products available to Canadians. These products include drugs,
disinfectants and sanitizers with disinfectant claims.
Head quarters of this Health Canada is at Ottawa, Ontario, Canada.
25. Regulatory process for drug in Canada
The exhibit shows the steps in the regulatory process for drugs in
Canada, from pre market to post market. The pre-market part of the
process starts with pre-clinical studies. The steps are:
Pre-clinical studies.
Clinical trails.
Regulatory product submission.
Submission review.
Market authorization decision.
Public access.
Surveillance, inspection, and investigation.
The post-market part of the process begins with the surveillance,
inspection, and investigation when a drug has been made accessible to
public.
26. APPLICATIONS OF HPFB
1)NEW DRUGS
a)New drug submission:
Required for the new drugs that have not been sold in Canada for a
sufficient time and sufficient quantity to establish their safety and
effectiveness, includes clinical trail information and details on production,
packaging conditions for use and side effects.
Service standard for first review decision takes 300 calendar days.
b)Supplemental new drug submission:
Required if substantial changes are made to a drug previously
approved as new drug submission, including dosage form, drug strength,
method of manufacture and labelling.
Service standard for first review decision takes 300 calendar days.
27. 2)GENERIC DRUGS
a)Abbreviated new drug submission:
Required for a new drugs; submissions must include evidence that
the generic is equivalent to the existing patented drug ( delivers the same
amount of medicinal ingredient and at the same rate ).
Service standard for first review decision takes 180 calendar days.
b)Supplemental abbreviated new drug submission:
Required if changes are made to a new generic product that was
previously approved as an abbreviated new drug submission, including
method of manufacture, labelling, recommended route of administration or a
new indication.
Service standard for first review decision takes 180 calendar days.
28. 3) OVER-THE COUNTER DRUGS
a)Drug identification number application ( DIN-A ):
This application is used most commonly for over-the-counter
drugs that have established safety records but that require additional
supporting data and a clinical review.
Service standard for first review decision takes 210 calendar days.
b)Drug identification number application (DIN-F ):
This application is used mostly for over- the-counter drugs that
comply with existing drug labelling and that do not require additional
supporting scientific data.
Service standard for first review decision takes 45 calendar days.
29. 4)POST-MARKETING CHANGES
a)Chemistry or manufacturing changes:
Manufacturers must inform health Canada, of changes to a drug
that could adversely affect its safety, purity, potency or effectiveness.
Service standard for first review decision takes 90 calendar days.
b)Labelling and product monograph changes:
Manufacturers must inform health Canada, of changes to a drug
that could affect the labelling of a product that is route of adminstration,
drug dose, precautions and warnings.
Service standard for first review decision takes 90 calendar days.
30.
31. MHRA
Medicines and healthcare products regulatory agency
(MHRA) was set up in April 2003 from a merger of the
medicines control agency and the medical devices
agency. The MHRA is the UK government agency which
is responsible for ensuring that medicines and medical
devices work, and are acceptably safe.
Aims of MHRA:
Protecting public health through regulation.
Promoting public health by helping people.
Improving public health by encouraging and facilitating developments in
products that will benefit people
32. The MHRA’s Activities:
Assessing the safety, quality and efficacy of medicines and authorizing their
sale and supply in the UK for human use.
Operating post-marketing surveillance and other systems for reporting,
investigating and monitoring adverse reactions to medicines and adverse
incidents involving medicinal devices.
Operating a proactive compliance Programme for medical devices.
Regulating clinical trails of medicines and medical devices.
Monitoring and ensuring compliance with statutory obligations relating to
medicines and medical devices through inspection.
Promoting good practice in the safe use of medicines and medical devices.
Managing the general practice research database (GPRD) and the British
pharmacopoeia (BP).
Offering scientific, technical and regulatory advice on medicines and
devices.
33. MHRA’s ORGANISATION
1) The agency board is made up of non-executive chairman, six non-executive
members and the agency’s CEO who is responsible for service delivery.
2) The executive board consisting of the agency’s directors, takes overall
responsibility for day-to-day management, strategic decision-making, line
management and all financial, policy, operational management issues.
3) The risk and adult committee provides independent feedback to the chief
executive and the management board on the effectiveness of risk
management process.
35. PMDA
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese
regulatory agency. working together with ministry of health, labour and
welfare (MHLW).
It’s obligation is to protect the public health by assuring safety, efficacy
and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of
pharmaceuticals and medical devices, monitoring of their post-marketing
safety and also responsible for providing relief compensation of sufferers
from adverse drug reaction and infections by pharmaceuticals, biological
products.
36. Pharmaceuticals and Medical Devices Agency (PMDA) is a consolidation of the services of;
1. PMDEC-Pharmaceuticals and Medical Devices Evaluation.
2. OPSR-Organization for Pharmaceutical Safety and Research.
3. JAAME-Japan Association for the Advancement of Medical Equipment.
Head quarters of PMDA is at Tokyo, Japan.
PMDA is the second largest pharmaceutical market in the world, with a market share of
$4.843 Trillion
Three major functions of PMDA
1. Review and Audit for Drugs and Medical devices.
2. Post-marketing safety operations for Drugs and Medical devices.
3. Relief service for ADR and other infections disease.
37. APPLICATION FORMS OF PMDA
1. Clinical trial application.
2. New Drug Approval (NDA) application.
3. Generic drug approval application.
4. Orphan drug application.
5. Priority review.
