Comparison Review of Two Regulatory Agencies Regulation: Therapeutic Goods Administration (TGA) and the European Medicine Agency (EMA) in Relation to Good Manufacturing Practice (GMP) Guideline

https://doi.org/10.22146/farmaseutik.v17i2.60237

Farida Aziza(1*)

(1) Graduate School of Health, University of Technology Sydney
(*) Corresponding Author

Abstract


There are some regulatory bodies in the world that impacting the pharmaceutical industry to operate and perform Good Manufacturing Practice (GMP) principles. These regulatory bodies exist to ensure that the pharmaceutical product and other human supporting products have a high standard of quality, safety, and efficacy from product registration to product distribution to the patient. This article reviews some aspects which is regulated by two of regulatory entities including Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) in relation with Good Manufacturing Practice (GMP) principles. The GMP principles which is structured by these regulatory agencies may be originally created by the agencies or influenced by other regulatory body concepts. The guidance can be a primary source or second reference for the pharmaceutical industry in impacting countries depending on the guideline’s legal status. It is noticeable that both regulatory bodies have some similar concepts to support GMP implementation and some differentt practices which may be considered by the pharmaceutical industry when it is aimed to market their product in the regulated countries.

 


Keywords


Good Manufacturing Practice; regulatory agencies; pharmaceutical industry; guideline

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References

European Commission n.d., EU Legislation, viewed 14 March 2019, https://ec.europa.eu/health/documents/eudralex_en. European Medicines Agency (EMA) n.d., Good Manufacturing Practice, viewed 15 March 2019, <https://www.ema.europa.eu/en/human-regulatory/research- development/compliance/good-manufacturing-practice>. European Medicines Agency n.d., Mutual recognition agreements, viewed 15 March 2019, <https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra>. European Medicines Agency n.d., What we do, viewed 16 March 2019, <https://www.ema.europa.eu/en/about-us/what-we-do>. Food and Drug Administration 2018, FDA Mission, viewed 29 September 2020 < https://www.fda.gov/about-fda/what-we-do>. 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. Therapeutic Goods Administration (TGA) n.d., About the Australian therapeutic goods legislation, viewed 16 March 2019, < https://www.tga.gov.au/about-australian-therapeutic-goods-legislation>. Therapeutic Goods Administration (TGA) n.d., International agreements and arrangements for GMP clearance, viewed 16 March 2019, < https://www.tga.gov.au/international-agreements-and-arrangements-gmp-clearance>. Therapeutic Goods Administration (TGA) n.d., Manufacturing medicines, viewed 15 March 2019, <https://www.tga.gov.au/manufacturing-medicines>. Therapeutic Goods Administration (TGA) n.d., Overview of supplying therapeutic goods in Australia, viewed 16 March 2019, < https://www.tga.gov.au/overview-supplying-therapeutic-goods-australia>. Therapeutic Goods Administration (TGA) n.d., TGA-NATA MoU relating to the regulation of in-house IVDs, viewed 16 March 2019, <https://www.tga.gov.au/tga-nata-mou-relating-regulation-house-ivds>. Therapeutic Goods Administration (TGA) n.d., What the TGA regulates, viewed 16 March 2019, <https://www.tga.gov.au/what-tga-regulates>.



DOI: https://doi.org/10.22146/farmaseutik.v17i2.60237

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