Regulatory Concepts Basic terminology,Guidelines, Regulations
Regulatory Concepts Investigational Product Guidelines, Regulations
Regulatory Concepts A newly developed medication created by a manufacturer.Basic terminology
Phase III Clinical Study
A randomized trial conducted by the manufacturer to evaluate the benefits and risks of an investigational product.
Active Comparator (Active Treatment or Active Control)
An effective medical treatment used as a control condition in clinical studies.
Placebo
A treatment with no medical effect used as a control condition in clinical studies.
Three-Arm Study
A clinical trial in which patients are randomly assigned to one of three conditions: (1) investigational product, (2) active comparator, or (3) placebo.
Two-Arm Head-to-Head Study (Comparative Trial)
A clinical trial where patients are randomly assigned to one of two conditions: (1) investigational product or (2) active comparator.
Superiority to Placebo
A clinical study aimed at proving that the difference in primary outcomes between the investigational product and placebo is statistically significant, favoring the new medication.
Superiority to an Active Comparator
A clinical study designed to show that the difference in primary outcomes between the investigational product and an active comparator is statistically significant, favoring the new medication.
Non-Inferiority to an Active Comparator
A clinical study aimed at demonstrating that the investigational product is not clinically inferior in efficacy compared to an active comparator.
Efficacy in Absolute Terms
An investigational product that has shown evidence of superiority to placebo but not to an active comparator.
Added Value
An investigational product that has shown evidence of superiority to an active comparator.
Compulsory Requirements
According to EMA guidelines, certain study designs are essential to demonstrate the efficacy of an investigational product for a specific disorder. These studies must be conducted to obtain marketing authorization.
Recommended Studies
According to EMA guidelines, some study designs are methodologically suitable to prove the efficacy of an investigational product for a specific disorder. These studies are recommended for obtaining marketing authorization, although the EMA acknowledges that alternative designs may also be acceptable
Guidance, Guidelines, Regulations Regulatory Concepts
Indian Regulations & Guidelines
Central Drugs Standard Control Organization (CDSCO) The CDSCO, under the Ministry of Health & Family Welfare, Government of India, provides comprehensive information about drug regulatory requirements in India.
Drugs (Price Control) Order 1995 and NPPA Orders The National Pharmaceutical Pricing Authority (NPPA) enforces the Drugs (Price Control) Order 1995 and other related orders. You can view the list of drugs under price control through NPPA.
The Drugs & Cosmetics Act, 1940 This act regulates the import, manufacture, distribution, and sale of drugs in India.
Schedule M of the D&C Act Specifies the general and specific requirements for factory premises, materials, plant, and equipment, as well as the minimum recommended areas for basic installations for certain categories of drugs.
Schedule T of the D&C Act Prescribes Good Manufacturing Practice (GMP) specifications for the manufacture of Ayurvedic, Siddha, and Unani medicines.
Schedule Y of the D&C Act Outlines the legislative requirements for clinical trials. The Ministry of Health, along with the Drugs Controller General of India (DCGI) and the Indian Council for Medical Research (ICMR), has developed draft guidelines for research involving human subjects. These Good Clinical Practice (GCP) guidelines are based on the Declaration of Helsinki, WHO guidelines, and ICH requirements for GCP.
The Pharmacy Act, 1948
Regulates the profession of pharmacy in India.
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
Controls the advertisement of drugs and remedies with misleading claims.
The Narcotic Drugs and Psychotropic Substances Act, 1985
Regulates the control and monitoring of operations relating to narcotic drugs and psychotropic substances.
Important International Guidelines and Regulatory Bodies Regulatory Concepts
World Health Organization (WHO)
- WHO Medicines Guidelines: Cover policies on medicine, intellectual property rights, financing, supply management, quality and safety, selection and rational use of medicines, technical cooperation, and traditional medicines.
- WHO General Health Guidelines: Address all areas relevant to global health.
International Conference on Harmonization (ICH) Provides guidelines for the registration of pharmaceuticals for human use, defining quality, safety, efficacy, and related aspects for developing and registering new medicinal products in Europe, Japan, and the United States.
Organization for Economic Cooperation and Development (OECD) An international organization with 30 member countries, addressing economic and social issues, including health care.
European Medicines Agency (EMEA) A decentralized body of the European Union based in London, providing guidelines for inspections, reporting, and all aspects of human and veterinary medicines in the EU.
US Food and Drug Administration (FDA) Provides regulations, guidelines, notifications, news, and communications related to food and drug safety and efficacy in the United States.
TGA
The Therapeutic Goods Administration (TGA) is the regulatory body in Australia responsible for issuing specifications that regulate medicines, medical devices, blood, tissues, and chemicals.
Department of Health, South Africa
The governmental department in South Africa overseeing public health matters.
WTO
The World Trade Organization (WTO) is a global international organization that deals with the rules of trade between nations. It provides news, resources, documents, and publications related to international trade.
Codex Alimentarius
The Codex Alimentarius Commission, under the Joint FAO/WHO Food Standards Programme, adopts a collection of international food standards and guidelines for processed, semi-processed, and raw foods.
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is responsible for ensuring the efficacy and safety of medicines and medical devices. It provides news, warnings, information, and publications.
Health Canada
The Federal Department responsible for health-related issues in Canada, providing advisories, warnings, recalls, reports, publications, activities, legislation, and guidelines.
Thai Food and Drug Administration
Oversees laws and regulations concerning drugs, food, cosmetics, and narcotics in Thailand.
Health Sciences Authority (HSA)
The regulatory body in Singapore responsible for health product regulation.
Department of Health, Philippines
The governmental department in the Philippines overseeing public health matters.
Medsafe
The New Zealand Medicines and Medical Devices Safety Authority, responsible for regulating the safety of medicines and medical devices in New Zealand.
NPCB, Malaysia
The National Pharmaceutical Control Bureau (NPCB) in Malaysia issues regulatory information, news, and publications related to the control and safety of pharmaceuticals.
DGMP, Belgium
The Directorate-General Medicinal Products (DGMP) in Belgium provides guidelines and useful information to ensure the safety, efficacy, and quality of medicines.
BfArM, Germany
The Federal Institute for Drugs and Medical Devices (BfArM) in Germany issues licensing and registration guidelines for medicinal products to ensure their safety and efficacy.
SwissMedic
SwissMedic is the Swiss regulatory agency responsible for the authorization and supervision of therapeutic products in Switzerland.
NAFDAC, Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria issues news, regulations, and guidelines to regulate food and drug safety.
MPA, Sweden
The Medical Products Agency (MPA) in Sweden issues regulatory and surveillance guidelines to ensure the safety and quality of medical products.