Post-authorization stage of product cycle | Pepgra

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What is Product cycle?

In pharmaceutical industry, product cycle consists of all processes from drug discovery to launch to access, which is closely monitored by regulatory bodies like European Medicines Agency (EMA) for European Union (EU) and Food and Drug Administration (FDA) for us (US).

Post-authorization stage of product cycle.

The various stages include: –
  1. Discovery and development.
  2. Preclinical research.
  3. Clinical research with 3 phases.
  4. Regulatory body review.
  5. Post-authorization / Post-market monitoring.

Stage of post-authorization:

Drug efficacy and safety is studied extensively during clinical trials; however, this is often still inadequate and a continued study on an equivalent is required from the users. this is often done by feedback on an equivalent from the top users within the market once the drug is introduced. This decides the lifetime of the drug within the pharmaceutical market.

United States-Food and Drug Administration (US-FDA):

The US-FDA gives detailed guidelines on the varied aspects of drug development process including post-market drug safety monitoring.

European Union:

European Medicines Agency (EMA) gives elaborate scientific and regulatory guidelines including pharmacovigilance to pharmaceutical companies for those products approved in Europe.

Current Trends in EU:

  • Limitation is that PAS covers only certain types of patient care and not the entire spectrum.

Additional guidelines for specialised areas:

  • For e.g. in case of orphan medicines that are drugs used in the treatment of rare conditions like inherited errors of metabolism, PASS is important and quick access to this information is important for effective treatment.

To Continue Reading : Post-authorization stage of product cycle


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