MEHERAB HOSSAN KEYAN

ID: 2017-3-70-048

SOPs to keep advertising in compliance with regulations

. Promotional activities should be consistent with the product labeling that has been cleared or
approved.

. Promotional claims should be reliable, accurate, truthful, informative, fair, balanced and upto
date, and we must be able to substantiate them.

. The information should not contain misleading or unverifiable statements or omissions likely to
induce medically unjustifiable product use or to give rise to undue risks.

. Any comparison of products should be factual and fair, and we must be able to substantiate it.

Drug Regulatory Affairs department provides:

. Licensing . Development
. Registration . Manufacturing
. Pricing . Marketing
. Pharmacovigilance . GMP
. Patent . GLP
. Copyright . GCP
. Trademark . Quality guidelines
 Major Regulatory Authority of different countries

COUNTRY REGULATORY AUTHORITY

US Food and Drug Administration (US FDA)

India central Drugs Standard Control Organization

Drug controller general of India (DCGI)

European Directorate for Quality of Medicines (EDQM)

Europe European Medicines Evaluation agencies (EMEA)

Australia Therapeutic Goods Administration (TGA)

UK Medicines and Health care products regulatory Agency (MHRA)

Bangladesh Directorate General of Drug Administration (DGDA)

Japan Japanese Ministry of health, Labour and Welfare (MHLW)

Canada Health Canada.

South Africa Medicine Control Council.

Brazil Agency Nacional Degradation Vigilancia Sanitaria(ANVISA)

 Differenr Regulatory Bodies

US FDA

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and
sanitary,human and veterinary drugs, biological products, and medical devices are safe and
effective, cosmetics are safe, and electronic products that emit radiation are safe.

FDA also ensures that these products are honestly, accurately and informatively represented to
the public.

US FDA Regulates:

 Biologics
 Cosmetics
 Drugs
 Foods
 Medical devices
 Radiation Emitting Electronic products
  Veterinary Products

FDA does not regulate

Advertising

The Federal Trade Commission is the federal agency which regulates all advertising,
excluding prescription drugs and medical devices. FTC ensures that advertisements are
truthful and not misleading for consumers.

Alcohol

The labeling and quality of alcoholic beverages are regulated by the Treasury
Department's Bureau of Alcohol, Tobacco, and Firearms (ATFS).

Consumer Products

While FDA regulates a large portion of the products that consumers purchase, the agency
has no jurisdiction over many household goods. The Consumer Product Safety Commission
(CPSC) is responsible for ensuring the safety of consumer goods.

Drugs of Abuse

Illegal drugs with no approved medical use such as heroin and marijuana are under the
jurisdiction of the Drug Enforcement Administration.

Health Insurance

FDA does not regulate health insurance, the cost of health care products or procedures, or
reimbursement for health and medical expenses.

Meat and Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Service is responsible for
the safety and labeling of traditional meats and poultry.

Pesticides

USDA and the Environmental Protection Agency share the responsibility for regulating
pesticides. EPA determines the safety and effectiveness of the chemicals and establishes
tolerance levels for residues on feed crops, as well asfor raw and processed foods. Restaurants
and Grocery Stores Inspections and licensing of restaurants and grocery stores are typically
handled by local county health department.

FDA's Role and Responsibilities:

  FDA regulating drugs, foods, cosmetics, biologics and medical devices.
 FDA is responsible for administration, enforcement, interpretation of US drug law and
has power to establish regulations which have the force and effect of law .

 FDA has developed policies, procedures and regulations to implement its Reglatory
initiatives, some going beyond the intent of the original laws.

MEDICINES CONTROL COUNCIL (MCC) SOUTH AFRICA

 The Medicines Control Council (MCC) is a statutory body that was established in terms
of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the
regulation of medicines in South Africa.

 It is appointed by the Minister of Health and its main purpose is to safeguard and protect
the public through ensuring that all medicines that are sold and used in South Africa are
safe, therapeutically effective and consistently meet acceptable standards of quality.

Central Drugs Standard Control Organization (INDIA)

Functions of CDSCO:

 Approval of new drugs and clinical trials

 Import Registration and Licensing
 License approving of Blood Banks, LVPS, Vaccines, r-DNA products & some
Medical Devices (CLAA Scheme)
 Amendment to D &C Act and Rules
 Banning of drugs and cosmetics
 Grant of Test License, Personal License, NOCs for Export
 Testing of New Drugs
 Oversight and market Survillance through Inspectorate of Centre Over and above
the State Authority

UK-MHRA:
(Medicines and Healthcare products Regulatory Agency)
 The MHRA regulates :
 Medicines Devices
 Tissue Engineering
 Nanotechnology
 Blood
The term "medicines" embraces both pharmaceutical and biological medicines,
and vaccines

European Medicines Evaluation agencies (EMEA)

EMEA-Functions:

 Pharmacovigilance
 Product defects reporting (PDR)
 Certification of a Medical Product
 PMF/VAMF Certifications
 Medicine for human or animal use.
 Paediatric formulation advantages.

World Health Organization(WHO)

WHO is the directing and coordinating authority for health within the United
Nations system.It is responsible for providing leadership on global health matters,
shaping the health research agenda, setting norms and standards, articulating
evidence-based policy options, providing technical support to countries and
monitoring and assessing health trends.Many countries follow the guidelines
provided by WHO.

 Food and Drugs Control Authority India follows WHO guidelines.

WHO GMP certification is a requirement and well accepted in most of the
countries across Asia, Africa, CIS and Latin America.

WHO's main functions:

 To act as the directing and coordinating authority on international health

work .
 To encourage technical cooperation for health with Member States.
 Has constitutional mandate to develop norms and standards.
 REFERENCES:
 https://www.pharmaguideline.com
 https://www.pharmatutor.org
 https://www.sciencedirect.com