Relevant bibliographies by topics / Drug Regulatory Authority

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Drug Regulatory Authority'

Author: Grafiati
Published: 4 June 2025
Last updated: 1 August 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'Drug Regulatory Authority.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "Drug Regulatory Authority"

1

S., D. Dhole* R. B. Darade. "Indian Pharmaceutical Regulatory Authority: Review." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1109–19. https://doi.org/10.5281/zenodo.11235269.

Full text
Abstract:
Central Drug Standard Control Organization is Regulatory Authority in India. CDSCO is responsible for conducting Clinical trials for new drug and provide approval to the new drug. CDSCO also monitors the Rules and Regulation regarding various medicinal practices in India. Functions of CDSCO include ensuring the quality of drugs, Medical Devices and cosmetics sold in the country, approval of new drugs and regulating clinical trials.
APA, Harvard, Vancouver, ISO, and other styles
2

Jayasuriya, L. "The drug regulatory authority." Ceylon Medical Journal 45, no. 2 (2015): 87. http://dx.doi.org/10.4038/cmj.v45i2.8012.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Abhishek, Deshmukh* Tejas Sharma Dr. Shivshankar Mhaske Krushna Tayade kasim Bhuriwale. "CDSCO: pharmaceutical regulatory authority of India." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 101–6. https://doi.org/10.5281/zenodo.14789469.

Full text
Abstract:
Central Drug Standard Control Organization is Regulatory Authority in India. CDSCO Is responsible for conducting Clinical trials for new drug and provide approval to the New drug. CDSCO also monitors the Rules and Regulation regarding various medicinal Practices in India. Functions of CDSCO include ensuring the quality of drugs, Medical Devices and cosmetics sold in the country, approval of new drugs and regulating clinical Trials
APA, Harvard, Vancouver, ISO, and other styles
4

Adukondalu, D., Rajesh Rajesh, Shaik Thaslim, E. Soumya, and M. Chandana. "Regulatory Guidelines for New Drug Development." Pharmaceutics and Pharmacology Research 4, no. 3 (2021): 01–11. http://dx.doi.org/10.31579/2693-7247/046.

Full text
Abstract:
Aim: The aim of present project work is to understand the guidelines and regulatory requirements for investigational new drug and development of new drug Objectives: The objective of current project include Need of a new drug to investigate New drug development targets Understanding the properties of new dug Required protocols for submission of new drug to regulatory authority Regulatory requirements to get approval of new drug.
APA, Harvard, Vancouver, ISO, and other styles
5

Kolte, Yash Raju. "Regulatory Authority in Pharmacovigilance." International Journal for Research in Applied Science and Engineering Technology 11, no. 12 (2023): 148–57. http://dx.doi.org/10.22214/ijraset.2023.57254.

Full text
Abstract:
Abstract: Based on their Gross National Income (GNI) per capita, the World Bank has categorized 80 economies as HighIncome. Global pharmacovigilance rules are primarily driven by three major regulatory stakeholders: the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA). This article's goal is to provide an overview of pharmacovigilance systems and procedures in high-income nations, especially those that are also International Conference on Harmonization (ICH) members. Every high-income nation is a part of the WHO
APA, Harvard, Vancouver, ISO, and other styles
6

Bandarapalle, Kishore, Rajasekhar Komarla Kumarachari, Kamasani Teja Sri, et al. "A Review on regulatory affairs and regulatory requirements for drug approval." Future Journal of Pharmaceuticals and Health Sciences 4, no. 1 (2024): 26–38. http://dx.doi.org/10.26452/fjphs.v4i1.550.

Full text
Abstract:
Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of t
APA, Harvard, Vancouver, ISO, and other styles
7

Bandarapalle, Kishore. "A Review on regulatory affairs and regulatory requirements for drug approval." A Review on regulatory affairs and regulatory requirements for drug approval 4, no. 1 (2024): 26–38. https://doi.org/10.5281/zenodo.14650148.

Full text
Abstract:
Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of t
APA, Harvard, Vancouver, ISO, and other styles
8

Ashok, Kumar P., GM Renu, S. Gowda Suhas, HU Tejaswini, Kumar Vinay, and HN Yashwanth. "Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 404–9. https://doi.org/10.5281/zenodo.12186280.

Full text
Abstract:
Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on history, regulatory policy and organization, and re
APA, Harvard, Vancouver, ISO, and other styles
9

Mann, R. D. "EEC SUPRANATIONAL DRUG REGULATORY AUTHORITY BY 1992?" Lancet 332, no. 8606 (1988): 324–26. http://dx.doi.org/10.1016/s0140-6736(88)92369-0.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Rajendra, K. Songara, Yashwant, Singhal Manmohan, Gupta Vipul, and Promila. "Need for Hormonisation of Labelling of OTC drugs." International Journal of Current Pharmaceutical Review and Research 1, no. 1 (2010): 33–58. https://doi.org/10.5281/zenodo.12699623.

Full text
Abstract:
Over the counter (OTC) drugs are medicine that may be sold without a prescriptionand without a visit to a medical professional in contrast to prescription drugs. Readingthe product label is the most important part of taking care of when using OTCmedicines. There is increasing need for consumer to have easily readable andunderstandable information about OTC drugs. Information on active ingredients,warnings, indications, storage conditions, contraindications, directions, purposes andother information, must be legible and accessible as OTC drug products are nowwidely available and used without me
APA, Harvard, Vancouver, ISO, and other styles
More sources

Dissertations / Theses on the topic "Drug Regulatory Authority"

1

Sekhonyana-Khetsekile, Mabolaeng. "The development and preparation of a quality control dossier for registration of Artemisia Afra capsules for the treatment of chronic Asthma by the South African health products regulatory authority." University of the Western Cape, 2018. http://hdl.handle.net/11394/6432.

Full text
Abstract:
Magister Pharmaceuticae - Mpharm<br>The aim of this study was to determine quality control specifications needed for a dossier and an investigator's brochure of A. afra capsules, which can be used to motivate the registration and clinical testing of A. afra capsules in chronic asthma. The specific objectives were: (1) to establish the minimum product quality requirements for registration of A. afra capsules, (2) to prepare and pharmaceutically characterize a capsule product of A. afra freeze dried aqueous extract (FDAE) suitable for registration, and (3) to identify pharmaceutical product qual
APA, Harvard, Vancouver, ISO, and other styles

Books on the topic "Drug Regulatory Authority"

1

Staff, World Health Organisation. Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource Products: A Manual for a Drug Regulatory Authority. Stationery Office, The, 1999.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
2

Sekeres, Mikkael A. Drugs and the FDA. The MIT Press, 2022. http://dx.doi.org/10.7551/mitpress/13620.001.0001.

Full text
Abstract:
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA, Mikkael Sekeres—a leading oncologist and former chair of the FDA's cancer drug advisory committee—tells the story of how the FDA became the most trusted regulatory
APA, Harvard, Vancouver, ISO, and other styles
3

Dineen, Kelly K., and Adam J. Ruggles. Legal Regulation of Prescription Opioids and Prescribers. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199981830.003.0002.

Full text
Abstract:
Prescribing opioids and other controlled substances is challenging on myriad levels. Beyond the complexities and uncertainties of evaluating and treating patients in pain, the legal landscape is increasingly complicated. Even within the already highly regulated health care environment, opioid prescribing involves additional legal and regulatory constraints. This chapter provides an overview of the legal frameworks for opioid prescribing, including a brief history of opioid regulation in general and for addiction treatment. The federal Controlled Substances Act, Food Drug and Cosmetic Act, and
APA, Harvard, Vancouver, ISO, and other styles

Book chapters on the topic "Drug Regulatory Authority"

1

Solerte, Maria Laura, and Erich Cosmi. "Endocrine-Disrupting Chemicals and the Offsprings: Prenatal Exposure." In Environment Impact on Reproductive Health. Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-36494-5_9.

Full text
Abstract:
AbstractOver the last 10 decades, the changes in normal environmental conditions, directly or indirectly connected to the presence of several chemical substances released in various ways and means, for many territories, throughout the planet, have become extremely evident, as well as the relative consequences assessed, which involve numerous international working groups. Starting from territorial pollution and known environmental disasters, the World Health Organization, Food and Drug Administration, European Food Safety Authority, European Commission, other international regulatory agencies,
APA, Harvard, Vancouver, ISO, and other styles
2

R. Panade, Anurag, Varda S. Joshi, Sachin S. Mali, and Pratik P. Kudale. "Indian regulatory requirements." In Deep Science Publishing. Deep Science Publishing, 2025. https://doi.org/10.70593/978-93-49307-31-5_5.

Full text
Abstract:
Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
APA, Harvard, Vancouver, ISO, and other styles
3

T. Pawar, Ruturaj, Sachin S. Mali, and Abhishek R. Veer. "Quality Management Systems." In Deep Science Publishing. Deep Science Publishing, 2025. https://doi.org/10.70593/978-93-49307-31-5_4.

Full text
Abstract:
Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
APA, Harvard, Vancouver, ISO, and other styles
4

Naaz, Aaliya, and Shweta Verma. "PRO-DRUG DEVELOPMENT." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 8. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bipn8p2ch3.

Full text
Abstract:
Drug discovery and development is a complex and iterative process aimed at identifying, designing, and bringing new drugs to the market for the treatment of diseases. It involves a series of stages, starting from target identification and validation, hit generation, lead optimization, and preclinical research, followed by clinical trials, regulatory approval, and post-marketing surveillance. The process begins with the identification of potential disease targets, such as specific proteins or receptors involved in the disease process. Through various techniques, researchers explore these target
APA, Harvard, Vancouver, ISO, and other styles
5

Chaudhary, Mr Zaid, and Mr Jonny Kumar. "INTRODUCTION OF PHARMACY." In PRELIMINARY PHARMACEUTICS. KAAV PUBLICATIONS, 2023. http://dx.doi.org/10.52458/9788196830045.2023.eb.ch-05.

Full text
Abstract:
A pharmacopoeia serves as the authoritative reference manual for drug standards, officially recognized by a country or regulatory authority. It defines criteria for drug identity, purity, and potency within a specific region. The document includes monographs detailing drugs, sources, descriptions, testing methods, and formulas. Official compendia, such as the British Pharmacopoeia and Indian Pharmacopoeia, set legal standards, while non-official compendia like the Merck Index serve as secondary references. Pharmacopoeias play a vital role in ensuring drug uniformity, preventing adulteration, a
APA, Harvard, Vancouver, ISO, and other styles
6

Shorter, Edward. "Power Play." In Before Prozac. Oxford University PressNew York, NY, 2008. http://dx.doi.org/10.1093/oso/9780195368741.003.0004.

Full text
Abstract:
Abstract What happened to these successful members of the first drug set? They had various fates, through all of which runs the common thread of in- difference to science, the playing up of anecdotal risks rather than bal- ancing the risk-benefit ratio for public health, and the willingness to use the regulator’s awesome power for political purposes. The Food and Drug Administration had been more or less a one- horse operation when in the 1950s and especially in the 1960s it vastly expanded to become eventually the major regulatory agency we know today. It solidified its authority largely by t
APA, Harvard, Vancouver, ISO, and other styles
7

"The Agricultural Chemicals Regulatory Approval Process." In Pharmaceutical, Biotechnology and Chemical Inventions, edited by Duncan Bucknell. Oxford University PressOxford, 2011. https://doi.org/10.1093/9780199289011.003.0070.

Full text
Abstract:
Abstract This chapter outlines the regulatory frameworks for agricultural chemicals and veterinary medicines in Australia, China, India, Japan, the United States, and the European Union, each operating under distinct legislative structures. It Australia’s Agricultural and Veterinary Chemicals Code 1994 and the role of the Australian Pesticides and Veterinary Medicines Authority (APVMA) under the National Registration Scheme. It also describes how China requires Ministry of Agriculture approval under the Administrative Regulations on Pesticides and Chemical Fertilizer, while India operates unde
APA, Harvard, Vancouver, ISO, and other styles
8

"Medical Devices, Agricultural Chemicals, and Other Non-Pharmaceuticals." In Pharmaceutical, Biotechnology and Chemical Inventions, edited by Duncan Bucknell. Oxford University PressOxford, 2011. https://doi.org/10.1093/9780199289011.003.0081.

Full text
Abstract:
Abstract This chapter outlines how Australia, Canada, China, India, and Japan regulate agricultural chemicals, veterinary products, and medical devices, with a focus on data protection and product registration. It begins with Australia, where the Australia Pesticides and Veterinary Medicines Authority (APVMA) administers the National Registration Scheme. In Canada, some protection may exist under copyright law or common law trade secret principles, while in China, provisions exist to penalise drug regulators who disclose protected data or abuse their roles. The chapter notes how India lacks sp
APA, Harvard, Vancouver, ISO, and other styles
9

Tahir, Mr Abu. "Food Safety-I." In Edited Book of Dietary Supplements and Nutraceuticals [According to latest syllabus of B. Pharm-VIII Semester of Pharmacy Council of India]. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/nbennurdsch17.

Full text
Abstract:
Food Safety-I encompasses a comprehensive understanding of the regulatory frameworks governing food safety standards. Regulatory bodies like the Food Safety and Standards Authority of India (FSSAI), the U.S. Food and Drug Administration (FDA), and the Fruit Products Order (FPO) play crucial roles in ensuring the safety and quality of food products. FSSAI sets guidelines and standards for food safety in India, focusing on preventing contamination and promoting public health. The FDA oversees food safety in the United States, ensuring that food products meet stringent safety standards to protect
APA, Harvard, Vancouver, ISO, and other styles
10

Kalaiselven, Vivekanandan, Shatrunajay Shukla, Nikita Mishra, and Pawan Kumar. "Basics and Essentials of Medical Devices Safety Surveillance." In New Insights into the Future of Pharmacoepidemiology and Drug Safety [Working Title]. IntechOpen, 2021. http://dx.doi.org/10.5772/intechopen.97248.

Full text
Abstract:
Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical de
APA, Harvard, Vancouver, ISO, and other styles

Conference papers on the topic "Drug Regulatory Authority"

1

Sadia, Halima. "Drug Regulatory Authority Of Pakistan, Karachi, Pakistan “Drug Utilization Evaluation Of Ceftriaxone In A Tertiary Care Teaching Hospital Of Karachi, Pakistan." In International Conference on Biological Research and Applied Science. Jinnah University for Women, Karachi,Pakistan, 2022. http://dx.doi.org/10.37962/ibras/2022/142-143.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Stringer, B., K. Lowton, M. Cusinato, et al. "Patient-reported experiences and quality of life outcomes in the TB-PRACTECAL clinical trial: PRACTECAL-PRO." In MSF Scientific Day International 2023. MSF-USA, 2023. http://dx.doi.org/10.57740/0589-cg13.

Full text
Abstract:
INTRODUCTION The TB-PRACTECAL study trialed a shorter, more tolerable regimen of oral drugs than standard of care (SoC) – which can last for up to 20 months and involve both injectables and up to 20 tablets a day. In this sub-study, PRACTECAL-PRO, we measured and explored trial participant quality of life, experiences, and perspectives on treatment, to understand outcomes more fully. Both studies were conducted in Uzbekistan, South Africa, and Belarus. METHODS We conducted a mixed-methods evaluation using quality of life (QoL) surveys and in-depth interviews. Participants in investigational an
APA, Harvard, Vancouver, ISO, and other styles
3

Blanton, Paul S., and Allen C. Smith. "Response of Conventional Ring Closures of Drum Type Packages to Regulatory Drop Tests With Application to the 9974/9975 Package." In ASME 2002 Pressure Vessels and Piping Conference. ASMEDC, 2002. http://dx.doi.org/10.1115/pvp2002-1617.

Full text
Abstract:
DOT, DOE and NRC Type A and Type B radioactive material (RAM) transport packages routinely use industrial or military specification drums with conventional clamp ring closures as an overpack. Considerable testing has been performed on these type packages over the past 30 years. Observations from test data have resulted in various design changes and recommendations to the standard drum specification and use, enhancing the reliability of the overpack. Recently, performance of the 9975 conventional clamp ring closure design was questioned by the DOE Regulatory Authority. This paper highlights the
APA, Harvard, Vancouver, ISO, and other styles

Reports on the topic "Drug Regulatory Authority"

1

Kwesiga, Victoria, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317428.

Full text
Abstract:
With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active
APA, Harvard, Vancouver, ISO, and other styles
You might also be interested in the extended bibliographies on the topic 'Drug Regulatory Authority' for particular source types:
Journal articles
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography