IPAC-RS Pharmaceutical Aerosols Resource Center (PARC)

The IPAC-RS Pharmaceutical Aerosols Resource Center (PARC) brings you information about science and regulation of medicinal aerosols and delivery systems – including those involved in addressing COVID-19.  This page is updated regularly with up-to-date information from government agencies and other authoritative sources.

IPAC-RS Roundtables

 

  • IPAC-RS Digital-Devices Webinar Series:  

    • IPAC-RS has launched a Roundtable webinar series on digital devices for 2021.  Presented by subject matter experts in the pharmaceutical sciences, this is a unique opportunity to learn about the latest research and regulatory trends focused on digital devices.  

      • The first webinar in the series, What is a Digital Biomarker and Why Is It Important? is scheduled for Friday, September 10, 2021 from 9:00 – 11:00 AM US ET.  Click here for more information and to register.

      • The second webinar Beyond Usability/Human Factors for Digital Healthcare will be held on Tuesday, September 21, 2021 from 10:00 AM - 12:00 PM US ET. Click here for more information and to register.

    • SAVE THE DATES:   Additional Webinars are scheduled below.  Registration information for these webinars will be available shortly.

      • ​​​The third webinar Digital Devices Manufacturing and Design Considerations will be held on Wednesday, September 29, 2021 from 8:30 - 10:00 AM US ET.

      • ​The fourth webinar Business Case for Digital Devices will be held on Monday, October 4, 2021 from 10:00 AM - 12:00 PM US ET.

 

 

** Become an IPAC-RS member for full access to these materials.  Contact the IPAC-RS Secretariat (info@ipacrs.org) for information.

 

Key Publications  and Journals

 

 
 

"Inhalation 101" Resources and Courses

 

 

Regulatory Information and Guidance for Drugs and Drug-Device Combinations

Medicinal products for delivery via respiratory tract (orally inhaled or intranasal drug products) typically combine the medicinal formulation (“drug”) and a delivery system (“device”).  Depending on their configuration and primary mode of action, they are regulated as drugs, or as devices, or as drug-device combination products.   

Regulatory agencies around the world have been actively supporting efforts to curb and combat the SARS-CoV-2 pandemic, and to adjust their other activities accordingly. 

United States - Guidance for Drugs and Drug-Device Combinations

 

Europe - Guidance for Drugs and Drug-Device Combinations

Brazil - Guidance for Drugs and Drug-Device Combinations

China - Guidance for Drugs and Drug-Device Combinations

Inhalers and the Environment

  • IPAC is a consortium that addresses regulatory, scientific and technical topics related to the propellants used in metered dose inhalers (MDIs).

  • US Environmental Protection Agency (EPA) is responsible for issuing rules and guidances affecting MDI propellants. 

  • Kigali Amendment to the Montreal Protocol (intended to protect the ozone layer).

 

Medical Devices - Regulatory Information and Guidance

The regulation of medical devices is complex and often jurisdiction-specific. To help you better navigate this uncertainty, we have compiled the following list of resources of regulatory guidance and requirements by country. 

Brazil - Medical Devices

  • In response to the COVID-19 pandemic, Anvisa defined temporary criteria and procedures for certification of Good Manufacturing Practices for registration and post-registration changes of medicines, supplies, and health products. “Coronavirus: alternatives to GMP certification(March 13, 2020, Updated: March 18, 2020)

  • Anvisa is prioritizing the evaluation of products for the diagnosis of COVID-19 and other agents that cause respiratory infections. Covid-19: diagnostic products will have priority(December 3, 2020, Updated: March 18, 2020)

 

China - Medical Devices

 

Europe - Medical Devices

 

 

  • The regulation of medical devices in the European Union occurs at the member state level. For more guidance regarding the regulation of medical devices in a specific EU member state, see the following: 

 

 

Russia - Medical Devices

United States - Medical Devices

History of FDA regulation of medical devices 1976-2020

The Association for the Advancement of Medical Instrumentation® (AAMI) publishes resources to assist developers and manufacturers of ventilators and other medical equipment.

The US Food and Drug Administration’s Center for Devices and Radiological Health (FDA CDRH) is responsible for regulation of medical devices in the United States. CDRH publishes guidance documents for industry as well as information and resources for healthcare providers and general public. CDRH maintains a free public catalogue of regulatory tools for evaluation of medical devices.  Additionally, FDA CDRH maintains a webpage specifically dedicated to COVID-19 diagnostic tests, ventilators, and personal protective equipment (PPE).

Agencies of different countries do cooperate where appropriate.  See, for example:

 

 

European Medical Device Regulations (MDR)

​In Europe, Notified Bodies (NBs) are involved in review of medical devices.  Their exact role and processes are changing under the MDR.  Click here to access current information, including a list of Designated NBs.

 
 
 

General COVID-19 Resources