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India, Russia, Brazil, China, and South Africa are all developing nations that make up the BRICS. In these countries, the pharmaceutical market has grown significantly over the last 20 years. The administrative medication legislation and the medication administrative framework are essential to the expansion of the pharmaceutical industry. Considering how quickly the pharmaceutical sector is expanding, regulatory matters are crucial in the pharmaceutical industry. An organisationalendeavour serves as the point of contact between global government experts and the pharmaceutical industry. The goal of the current investigation is to evaluate the strengths and weaknesses of the current ERA technique for human medicines. Existing human medicine ERA frameworks have played crucial roles in enhancing ecological awareness of the pharmaceutical industry.We must work toward harmonisation to correct the disparities in the recommendations. such that a universal standard can be anticipated. The guidelines will need to be harmonised over time. However, once the rules are standardised, developing nations like the BRICS would profit. The sector anticipates regulatory harmonisation with ICH formation, allowing for simple submission. We believe that all regulations should be harmonised and harmonised for the benefit of business.


Regulatory Requirements, Registration Process, Brazil, Russia, India, China and South Africa (BRICS), Generic Products.

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