What’s Regulatory Affairs in actuality?

In the pharmaceutical aspect, Regulatory Affairs is the name of the profession in which the officer creates a positive link between the pharmaceutical industry and Drug Regulatory authorities worldwide. Mainly, it’s considered at the time of drugs and their product registration in various countries before proceeding towards marketing.

Objectives of Regulatory Affairs Professionals:

Protection and Safety of Human beings.
Maintaining the quality of drugs to avoid risk.
Stability of product information accuracy

Functions of Regulatory Affairs professionals:

→ Work as a liaison under regulatory agencies.
→ Prepare authentic and scientifically valid ANDA, NDA, INDA, DMF, and MAA submissions. e.t.c.
→ Promote the valuable agreement with all the applicable ICH, cGMP, GLP, and GCP guidelines, rules, and laws.
→ Avail expertise and regulatory intelligence to get practical, workable plans by translation from regulatory requirements.
→ Guide the companies on regulatory aspects that can influence their proposal.

Modifications in the proposal to increase the chance of acceptance:

• Modify strength
• Modify the form of dose
• New combination Product
• Change active ingredient
• New indication
• Change in formulation
• Replace active ingredient with formulation product
• Change in dosing regimen
• Move from prescription indication towards OTC indication
• Recombinant active/ Naturally derived ingredient
  Bioequivalence

ICH:

In this project, the regulatory authorities of the US, Europe, and Japan experts from the pharmaceutical industry linked together in the three regions to discuss technical and scientific aspects of pharmaceutical product registration.

CTD:

It’s a union of specifications for the registration of Medicines and application dossiers and is created to be used across the US, Europe, and Japan. Efficacy, Quality, and Safety are considered in a common format through CTD. ICT is responsible for CTD maintenance.

Important points to know:

→ The date limit is up to five years after the acceptance of the application. 

→ The medicines’ prices are regulated by Costing and Pricing Committee.

→ The triplicate hard copies and a soft copy are created for the DRAP submissions. One triplicate hard copy is for office record.