MPT Regulatory Guidance Hub - The IMPT

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)

Guideline on clinical investigation of steroid contraceptives in women (2005)

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)

Q1A(R2) Stability Testing of New Drug Substances and Products (2003)

Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (1995)

Multipurpose Prevention Technologies: Technology Landscape and Potential for Low- and Middle-Income Countries (2021)

Introducing New Contraceptive Options: Product Registration Basics for Global Health Program Managers (2021)

Assessment Report Dapivirine Vaginal Ring 25 mg (2020)

Regulatory Assessment — Learning about Expanded Access and Potential of the Levonorgestrel Intrauterine System (LEAP LNG-IUS) (2018)

Building MPT acceptability during product development through consumer and health systems research (2017)

Building capacity for MPT product development (2017)

Aide-mémoire (2013)

Nonclinical Development Needs and Regulatory Requirements for Multipurpose Prevention Technologies: A Primer (2012)

Reflection paper on the non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP) (2012)

What Regulatory Guidance Exists for Multipurpose Prevention Technologies (MPTs)? A Review of Key Guidance Documents and Their Applicability to MPTs (2011)

Notes from Population Council Day of Dialogue on “Multipurpose Prevention Technologies: Toward Clarity in Nomenclature” (2011)

Facilitating Regulatory Approval of Multipurpose Prevention Technologies for Sexual and Reproductive Health (2011)

EECO Product Registration Toolkit (2023)

Inactive Ingredient Search for Approved Drug Products (2022)

ClinRegs – Online Database of Country-Specific Clinical Research Regulatory Information (2015)

M4: The Common Technical Document (2003)

Considerations when Transitioning an MPT Product Candidate from Preclinical to Clinical Development (2022)

MPT Regulatory Pathways: Case Studies From MPT Product Developers (2022)

Combining Active Pharmaceutical Ingredients: MPT Development & Regulatory Considerations (2021)

Toxicity study considerations for HIV prevention and MPT R&D (2021)

Bioavailability/Bioequivalence Strategies for MPTs – Feasibility and Risks (2016)

MPT Acceptability in Uganda, Nigeria and South Africa (2014)

Regulatory Considerations with Developing Combination Products (2014)

MPT Product Development & Regulatory Issues 101 (2014)

The Development of Two Multipurpose Prevention Technology (MPT) Products, the Regulatory Pathway for Each, and the Initiation of Clinical Studies (2013)

A Critical Look Down the Critical Path to MPT Development (2013)

What Have We Learned From Other Reproductive Health Technologies? (2012)

Considerations for the Regulatory Approval of Multipurpose Prevention Technologies (MPTs) (2012)

Users’ and Providers’ Perspectives on MPTs: What do we know, and what do we need to know? (2012)

Regulatory Pathways for MPTs: Distilling and Clarifying the Process (2012)

Donation of Contraceptive Products through Special Import Permits: A Case Study in Zambia and Nigeria (2020)

Africa Analysis: Getting combination tools to fight HIV (2014)

Lessons from reproductive health to inform multipurpose prevention technologies: Don’t reinvent the wheel (2013)

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