IPAC-RS

History

IPAC-RS was formed as part of the International Pharmaceutical Aerosol Consortium (IPAC) in 1999 and established in 2001 as a separate Consortium, with the mission to enhance the quality and availability to patients of orally inhaled and nasal drug products (OINDP) through scientifically driven advancements related to development and regulation of these products.

Timeline

1999: An IPAC working group was formed to prepare comments on the FDA draft CMC Guidance for MDIs and DPIs and BA/BA Guidance for nasal sprays.

2001: The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) became a separate consortium. IPAC-RS formed technical teams on Supplier Quality, Leachables & Extractables, Specifications (with working groups on Cascade Impaction and Delivered Dose Uniformity), Tests & Methods, and Bioequivalence/Bioavailability.

2002: A Foreign Particles working group was formed to address regulatory questions.

2003: A Model OINDP group formed to proactively develop guidance on how QbD concepts would be incorporated into the pharmaceutical development section of the FDA Common Technical Document for OINDP.

2004: IPAC-RS and USP formed a collaboration to clarify microbiological methods for OINDP.

2006: The OINDP Materials working group was established to address regulatory agencies' focus on testing for special case compounds. IPAC-RS also hosted its first public conference on Inhalation and Nasal Drugs: The Regulatory Landscape. Additionally, a new working group was established to explore quality-by-design (QBD) of Analytical Methods, especially as they apply to OINDP.

2007: The Risk Management working group formed because of regulatory risk management initiatives.

2008: The Global Regulatory Review & Outreach (GRRO) group formed to effectively liaise with other industry organizations and focus efforts on international regulatory intelligence and outreach. The Device working group formed to focus on QbD and device design. A Leachables & Extractables Development Paradigm and a Dissolution working group were established.

2010: IPAC-RS' Patient Concordance Knowledge Network effort started because of FDA Advisory Committee comments and other input to IPAC-RS.

2011: IPAC-RS' Global Regulatory Review & Outreach team started issuing World Bulletins reporting on regulatory systems and relevant policies in various countries, including Argentina, Australia, Brazil, Canada, China, Costa Rica, India, Japan, Korea, Mexico, New Zealand, the Philippines, Russia, Singapore, South Africa, Taiwan, Turkey, and several world regions.

2012: A Global Regulatory Review & Outreach focus group for Brazil was started. The Population Bioequivalence (PBE) working group formed when FDA published a guidance with a new form of the PBE test.

2013: A Global Regulatory Review & Outreach group focused on China was established.

2014: IPAC-RS established  the GRRO Turkey working group in response to a guideline on inhalation products issued by the Turkish medicines agency. A Subgroup on Combination Products Regulations was formed in response to FDA developments. IPAC-RS also hosted the Orlando Inhalation Conference: Approaches in International Regulation.

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Become an IPAC-RS member today Participation in IPAC-RS affords a variety of benefits including opportunities to shape the scientific and regulatory environment and tools to stay informed.

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