IPAC—RS has submitted comments to EMA on the “Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product”.Learn More
View IPAC-RS comments on the FDA draft guidance Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.Learn More
IPAC-RS has updated Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP) to reflect the 2017 regulatory landscape.Learn More
Read about recent additions to the IPAC-RS Member Webinar Series.Learn More
We are pleased to announce the 2017 IPAC-RS/ISAM Workshop in Santa Fe, New Mexico. View the final program.
The European Medicines Agency recently finalized a Guideline on the clinical investigation of medicinal products for the treatment of asthma. The guideline will be effective May 1, 2016. The current version of the guideline includes a section on the treatment of asthma in children, some considerations for the development of immunotherapy, and focuses on control-based management of the disease.
In a recent press briefing, EMA Executive Director Guido Rasi discussed his vision for the next five years. Dr. Rasi emphasized EMA’s commitment to transparency, patient involvement, and research and development for medicines that address public health needs. He also stressed the importance of strong cooperation between the member states, the European Commission, and other international partners.
The American National Standards Institute (ANSI) publically released its comments on the on the draft Chinese national standard “Association Standardization—Part 1: Guidelines for Good Practice.” The ANSI comments recommend that Chinese associations be required to open participation in the standards development process to all stakeholders and encourages Chinese associations to practice transparency during the development process.
New Zealand has updated its labeling guidance to include MHRA guidance published in 2014 as a best practice document for guidance on labelling and packaging of medicines.Learn More
The leader of the China Food and Drug Administration (CFDA), Bi Jingquan, has endorsed legislation reforming the drug approval process that would incentivize research and improve generic drug quality.
The CFDA has also issued guidance on the quality and efficacy of generic medicines for public feedback. According to RAPS, the draft document includes sections on the need for CFDA to retool its operation to oversee the consistent evaluation of generic filings and a call for a government-wide shift in approach to the sector.
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.