Review and Comparison of Food Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA) on Good Manufacturing Practice (GMP) Implementation

https://doi.org/10.22146/farmaseutik.v18i2.73520

Farida Nur Aziza(1*)

(1) Fakultas Farmasi Universitas Gadjah Mada
(*) Corresponding Author

Abstract


A government is responsible for ensuring public health and safety. One of the approaches is to establish a regulatory body that governs health-related items such as pharmaceuticals and other human health-related products. These regulatory bodies exist to ensure that goods satisfy high standards of quality, safety, and efficacy. This article investigates several aspects of regulatory bodies' regulation and Good Manufacturing Practice (GMP) standards controlled by two regulatory organizations, the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA). Both regulatory agencies appear to have some items controlled and fairly specific product authorization guidelines. It is apparent that both regulatory authorities have some comparable notions in common when it comes to GMP implementation, product registration, mutual recognition agreements, and MoU implementation.


Keywords


Food Drug Administration; Medicines and Healthcare products Regulatory Agency; good manufacturing practice; guideline

Full Text:

PDF


References

European Commission 2022, Eudaralex-Volume 4-Good Manufacturing Practice (GMP) guidelines, viewed 28 February 2022 < https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en>.

Feldmann, D. & Muller, HJ., 2012, Comparison of EU GMP Guidelines with WHO Guidelines, Deutsche Gesellschaft fur Internationale Zusammenarbeit (GIZ) GmbH, Bonn, Germany.

Food and Drug Administration 2021, Non-Profit and Other MOUs MOU 225-18-012, viewed 20 February 2022 <https://www.fda.gov/about-fda/non-profit-and-other-mous/mou-225-18-012>.

Food and Drug Administration 2022, CFR-Code of Federal Regulations Title 21, viewed 20 March 2022 < https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D>.

Food and Drug Administration 2022, FDA Mission, viewed 1 March 2022 < https://www.fda.gov/about-fda/what-we-do>.

Food and Drug Administration 2022, Mutual Recognition Agreement (MRA), viewed 1 March 2022 < https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra>.

Gouveia, BG, Rijo, P., Goncalo, TS, Reis, CP 2015, Good Manufacturing Practices for Medicinal Products for Human Use, J Pharm Bioall Sci 2015; 7:87-96. Available from: http://www.jpbsonline.org/text.asp?2015/7/2/87/154424.

Medicines and Healthcare products Regulatory Agency 2015, UK and India regulators agree on deal for closer collaboration to improve public safety, viewed 10 March 2022 < https://www.gov.uk/government/news/uk-and-india-regulators-agree-deal-for-closer-collaboration-to-improve-public-safety>.

Medicines and Healthcare products Regulatory Agency 2016, Improving international collaboration-MHRA and Swissmedic sign MoU, viewed 10 March 2022 <https://www.gov.uk/government/news/improving-international-collaboration-mhra-and-swissmedic-sign-mou>.

Medicines and Healthcare products Regulatory Agency 2020, Guidance Good manufacturing practice and good distribution practice, viewed 1 March 2022 < https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice>.

Medicines and Healthcare products Regulatory Agency 2021, Guidance Decentralised and mutual recognition reliance procedure for marketing authorizations, viewed 9 March 2022 < https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations>.

Medicines and Healthcare products Regulatory Agency 2022, About us, viewed 1 March 2022 < https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about>.



DOI: https://doi.org/10.22146/farmaseutik.v18i2.73520

Article Metrics

Abstract views : 2449 | views : 5890

Refbacks

  • There are currently no refbacks.


Majalah Farmaseutik Indexed by:

   
 
Creative Commons Licence
 
 
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.