Regulatory pathways are a critical and complex landscape to navigate. This is all the more complex with MPTs, since these products have multiple indications and many involve combining two or more active pharmaceutical ingredients (APIs).

This dynamic hub provides MPT product developers and other stakeholders with up-to-date global regulatory resources and considerations for success.

Browse our featured categories to find the right resources to support your work!

  • Glossary of Regulatory Terms (2022)
  • Principles of Premarket Pathways for Combination Products (2022)
  • Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” (2020)
  • ISO 14971: 2019 — Medical devices: Application of risk management to medical devices (2019)
  • Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry (2019)
  • Bioanalytical Method Validation: Guidance for Industry (2018)
  • Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Guidance for Industry (2017)
  • Guideline on clinical development of fixed combination medicinal products (2017)
  • Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products (2017)
  • Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection (2014)
  • Codevelopment of Two or More New Investigational Drugs for Use in Combination (2013)
  • ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals (2011)
  • M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (2010)
  • ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (2009)
  • End-of-Phase 2A Meetings: Guidance for Industry (2009)
  • Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (2006)
  • Antiviral Product Development: Conducting and Submitting Virology Studies to the Agency (2006)
  • Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors (2006)
  • Nonclinical Safety Evaluation of Drug or Biologic Combination (2006)
  • Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives (2005)
  • Guideline on clinical investigation of steroid contraceptives in women (2005)
  • Q1A(R2) Stability Testing of New Drug Substances and Products (2003)
  • Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (1995)
  • Please contact us if you have a resource that you would like included here or if you would like more support in finding exactly what you are looking for.