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Friday, 30 March 2018
Pharma ACTD Dossiers
Regulations & Guidelines
we understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements at home and in the regulated foreign markets. We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section.
Indian Regulations & Guidelines:
CDSCO-Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India.
NPPA-Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India.
D & C Act, 1940-The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
Schedule M-Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.
Schedule T-Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines.
Schedule Y-The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act.
GCP guidelines-The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR)has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice.
The Pharmacy Act,1948-The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954-The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities.
The Narcotic Drugs and Psychotropic Substances Act, 1985-The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.
International Guidelines and Regulatory Bodies:
WHO (Medicines)-WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.
WHO sites-WHO guidelines on all areas relevant to health of people all over.
ICH-International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States
OECD-Organization for Economic Collaboration and Developmentincluding 30 member countries covers economic and social issues in areas of health care.
EMEA-European Medicines Agency (EMEA), a decentralised body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union.
US FDA-Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.
TGA-Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.
South Africa-The department of Health, South Africa.
WTO-News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations.
Codex Alimentarius-Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.
MHRA-News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK.
Health Canada-Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.
Thai FDA-Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.
HSA, Singapore-Health Sciences Authority (HSA), the regulatory body of Singapore.
DOH, Philippines-The Department of Health, Philippines.
Medsafe, New Zealand-Medsafe, New Zealand Medicines and Medical Devices Safety Authority.
NPCB, Malaysia-Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.
DGMP, Belgium-Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.
BfArM, Germany-Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany
SwissMedic-Swiss regulatory agency for therapeutic products.
MPA, Sweden-Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden.
NAFDAC, Nigeria-News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.