Author(s):
Akshata A. Shinde, Akshada S. Gurav, Bharatee P. Chaudhari, Vivekkumar K. Redasani
Email(s):
akshatashinde2001@gmail.com
DOI:
10.52711/2231-5659.2024.00040 
Address:
Akshata A. Shinde, Akshada S. Gurav, Bharatee P. Chaudhari, Vivekkumar K. Redasani
YSPM's Yashoda Technical Campus, Faculty of Pharmacy, Wadhe, Satara, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 3,
Year - 2024
ABSTRACT:
Medicines play an important role in saving lives, maintaining health, preventing disease, curbing epidemics and promoting national economic development. This is why people, governments, the pharmaceutical industry and research institutes pay for drugs. However, to do this, the drugs must be safe, effective and of high quality. This means that the development, production, import, export and distribution of drugs are regulated to ensure that they meet prescribed standards. To effectively regulate medicines, the government has established strong National Regulatory Authorities (NRAs) to ensure that medicines are effectively regulated to protect and promote public health. Pharmaceutical regulations around the world play an important role in ensuring the safety, quality and efficacy of medicines. Medicines regulatory agencies are responsible for enforcing regulations and issuing guidelines for the development, licensing, registration, manufacture, labelling, storage, marketing, distribution, pricing of drugs, drug importation and post marketing studies. While seeking international markets, the pharmaceutical industry must comply with the pharmaceutical regulations of other countries with different regulatory requirements. A single regulatory approach for marketing authorization (MA) applications for medicines in different countries is difficult. Therefore, the Common Technical Document (CTD) was developed to provide a common format for the electronic submission of drug registration applications.
Cite this article:
Akshata A. Shinde, Akshada S. Gurav, Bharatee P. Chaudhari, Vivekkumar K. Redasani. A Review on Pharmaceutical Regulatory Authority of India, USA, UK, Australia. Asian Journal of Research in Pharmaceutical Sciences. 2024; 14(3):243-8. doi: 10.52711/2231-5659.2024.00040
Cite(Electronic):
Akshata A. Shinde, Akshada S. Gurav, Bharatee P. Chaudhari, Vivekkumar K. Redasani. A Review on Pharmaceutical Regulatory Authority of India, USA, UK, Australia. Asian Journal of Research in Pharmaceutical Sciences. 2024; 14(3):243-8. doi: 10.52711/2231-5659.2024.00040 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2024-14-3-9
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