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Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” September 2020 click to view Guidance Document In this Technical Brief: Product Type(s): Medical Devices Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research Visit Guidance Document September 2020
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry July 2019 click to view Technical Brief In this Technical Brief: Health Risk(s): Unintended Pregnancy Product Type(s): Hormonal Contraceptives Topic(s): Product Development Regulatory Issues Region(s): United States

Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration. Visit Guidance Document July 2019
Guideline on clinical development of fixed combination medicinal products

Guideline on clinical development of fixed combination medicinal products

Guideline on clinical development of fixed combination medicinal products March 2017 click to view Guidance Document In this Technical Brief: Product Type(s): Fixed combination medicinal products containing two or more active substances within a single pharmaceutical form Topic(s): Product Development Regulatory Issues Region(s): United States

Committee for Human Medicinal Products (CHMP), European Medicines Agency. Visit Guidance Document March 2017
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products January 2017 click to view Guidance Document In this Technical Brief: Product Type(s): Combination Products Topic(s): Manufacturing MPTs Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in the Office of the Commissioner, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Regulatory Affairs (ORA) Visit Guidance Document January 2017
Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection

Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection

Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection November 2014 click to view Technical Brief In this Technical Brief: Health Risk(s): HIV Product Type(s): ARVs Microbicides Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Visit Guidance Document November 2014
Guidance for industry, vaginal microbicides: Development for the Prevention of HIV infection

Guidance for industry, vaginal microbicides: Development for the Prevention of HIV infection

Guidance for industry, vaginal microbicides: Development for the Prevention of HIV infection November 2014 click to view Guidance Document In this Technical Brief: Product Type(s): Vaginal Microbicides HIV Prevention Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Visit Guidance Document November 2014
Codevelopment of Two or More New Investigational Drugs for Use in Combination

Codevelopment of Two or More New Investigational Drugs for Use in Combination

Codevelopment of Two or More New Investigational Drugs for Use in Combination June 2013 click to view Guidance Document In this Technical Brief: Product Type(s): MPTs Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Visit Guidance Document June 2013
ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals June 2011 click to view Guidance Document In this Technical Brief: Product Type(s): Pharmaceuticals Topic(s): Preclinical Safety Regulatory Issues Region(s): United States

European Medicines Agency Visit Guidance Document June 2011
ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals December 2009 click to view Guidance Document In this Technical Brief: Product Type(s): Pharmaceuticals Topic(s): Human Clinical Trials Marketing Authorization Regulatory Issues Region(s): United States

European Medicines Agency Visit Guidance Document December 2009
Nonclinical Safety Evaluation of Drug or Biologic Combination

Nonclinical Safety Evaluation of Drug or Biologic Combination

Nonclinical Safety Evaluation of Drug or Biologic Combination March 2006 click to view Guidance Document In this Technical Brief: Product Type(s): Combination Topic(s): Nonclinical Safety Evaluation Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Visit Guidance Document March 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

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

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 July 2005 click to view Guidance Document In this Technical Brief: Health Risk(s): STDs Vaginal Contraceptives Product Type(s): Combination Vaginal Contraceptives Topical Drugs Topic(s): Pharmacology / Toxicology […]

Division of Reproductive and Urologic Drug Products, Office of Drug Evaluation II, Division of Anti-infective Drug Products and Division of Antiviral Drug Products, Office of Drug Evaluation IV Visit Guidance Document July 2005
Guideline on clinical investigation of steroid contraceptives in women

Guideline on clinical investigation of steroid contraceptives in women

Guideline on clinical investigation of steroid contraceptives in women July 2005 click to view Guidance Document In this Technical Brief: Product Type(s): Steroid Contraceptives Topic(s): Clinical Investigation Product Development Regulatory Issues Region(s): United States

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Visit Guidance Document July 2005
Guidance for development of vaginal contraceptive drugs

Guidance for development of vaginal contraceptive drugs

Guidance for development of vaginal contraceptive drugs January 1995 click to view Guidance Document In this Technical Brief: Product Type(s): Vaginal Contraceptives Topic(s): Product Development Regulatory Issues Region(s): United States

Center for Drug Evaluation and Research, Food and Drug Administration Visit Guidance Document January 1995