One Product Development for Multiple Markets

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Developing a single product for multiple markets requires careful planning to meet the regulatory requirements of each target region.

Identify Target Markets & Regulatory Authorities

Each country or region has its own regulatory body that sets guidelines for pharmaceutical products. Key regulatory agencies include:

  • USFDA
  • EMA (EU)
  • MHRA (UK)
  • TGA (Australia)
  • Health Canada (Canada)
  • PMDA (Japan)
  • NMPA (China)
  • WHO-PQ
  • CDSCO (India)
  • MCC (South Africa)
  • ANVISA (Brazil)

Each authority has different requirements for formulation, stability, manufacturing, and documentation.

Harmonization Strategy

To avoid developing multiple versions of the same product, use harmonized guidelines:

  • ICH Guidelines: Follow ICH Q8-Q12 for product development, stability, and quality.
  • Pharmacopeial Compliance: Ensure compliance with USP, Ph. Eur., BP, IP, or JP based on target markets.
  • Common Technical Document (CTD/eCTD): Prepare dossiers in CTD format to facilitate submissions in multiple markets.

Formulation Development

  • Global API Selection: Choose an API source approved in multiple markets (e.g., USDMF, CEP, or DMF registered).
  • Excipients Compliance: Use excipients listed in major pharmacopeias (USP/NF, Ph. Eur., BP).
  • Manufacturing Considerations: Follow GMP as per PIC/S, EU-GMP, and WHO-GMP.
  • Dissolution Profile Matching: Ensure dissolution comparability across different reference products in multiple markets.

Stability Study Considerations

Follow ICH Q1A-Q1F for stability testing.

Perform studies in multiple climatic zones:

  • Zone I & II (Europe, US, Japan)
  • Zone III (Hot, dry regions)
  • Zone IVa & IVb (Hot & humid regions like ASEAN, India, Brazil)

Bioequivalence & Clinical Requirements

  • Waiver Possibility: Check BCS classification for biowaiver eligibility.
  • Multiple BE Studies: Conduct bioequivalence studies in reference markets (e.g., USFDA & EMA) to support multiple registrations.
  • Bridging Studies: If required by authorities (e.g., Japan or China).

Regulatory Documentation & Filing Strategy

  • Prepare a global dossier with minor modifications for different agencies.
  • Use CTD/eCTD format for easier submission across multiple markets.
  • Leverage Reference Approvals: If approved in stringent regulatory markets (USFDA, EMA), some countries accept abridged reviews.

Risk Assessment & Market-Specific Requirements

  • China: Local clinical study often required.
  • Japan: Stability data on Japanese patients preferred.
  • EU: Different variations (DCP, MRP) for marketing authorizations.
  • Latin America & ASEAN: Local dossier format variations may exist.

Pharmacovigilance & Post-Approval Commitments

  • Establish a global pharmacovigilance system as per ICH E2E.
  • Meet periodic PSUR PV requirements.

Conclusion

By aligning formulation, BE studies, stability, and regulatory submissions under harmonized guidelines (ICH, CTD, WHO-GMP),one can develop a single product for multiple markets.


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Resource Person: Moinuddin syed. Ph.D, PMP®

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