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 weekly with links to government agencies and other authoritative sources.

Key Publications  and Journals

 

 
 

Regulatory Information and Guidance

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. For an updated overview of government responses throughout the world to COVID-19, see the U.S. Department of Commerce’s Global Dashboard on COVID-19 Government Policies.

United States

 

Europe

Brazil

China

Medical Devices

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

  • 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

 

Europe

 

 

  • 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: 

 

 

United States

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. 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) – Getting Ready for May-2021 Implementation

​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

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