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IPRF – International Pharmaceutical Regulators Forum :: Homepage

International Pharmaceutical Regulators Forum (IPRF). Consolidation to create synergies in international collaboration: IGDRP and IPRF become IPRP. Back in 2016, discussions started about a possible consolidation of the two initiatives, the International Generic Drug Regulato. The IPRF agrees on a path forward and a new name. The new initiative will be named the International Pharmaceutical Regulators Programme (IPRP). IPRP will be officially launched. The International Pharmaceutical Regulators Forum pr...

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IPRF – International Pharmaceutical Regulators Forum :: Homepage | i-p-r-f.org Reviews

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International Pharmaceutical Regulators Forum (IPRF). Consolidation to create synergies in international collaboration: IGDRP and IPRF become IPRP. Back in 2016, discussions started about a possible consolidation of the two initiatives, the International Generic Drug Regulato. The IPRF agrees on a path forward and a new name. The new initiative will be named the International Pharmaceutical Regulators Programme (IPRP). IPRP will be officially launched. The International Pharmaceutical Regulators Forum pr...

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IPRF – International Pharmaceutical Regulators Forum :: Homepage | i-p-r-f.org Reviews

https://i-p-r-f.org

International Pharmaceutical Regulators Forum (IPRF). Consolidation to create synergies in international collaboration: IGDRP and IPRF become IPRP. Back in 2016, discussions started about a possible consolidation of the two initiatives, the International Generic Drug Regulato. The IPRF agrees on a path forward and a new name. The new initiative will be named the International Pharmaceutical Regulators Programme (IPRP). IPRP will be officially launched. The International Pharmaceutical Regulators Forum pr...

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i-p-r-f.org

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IPRF – International Pharmaceutical Regulators Forum :: News

https://www.i-p-r-f.org/en/news

Public Assessment Summary Information for Biosimilar (PASIB) final documents after consultation. The IPRF Biosimilars Working Group (IPRF BWG) has proposed the development of a template to assist National Regulatory Authorities (NRA) in making available a summary of the review of biosimilar applications in their country in a common language (e.g. English). Template for Public Assessment Summary Information for Biosimilar (PASIB). The IPRF met for the fifth time Public Summary/Public Statement. The Manage...

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IPRF – International Pharmaceutical Regulators Forum :: Meetings

https://www.i-p-r-f.org/en/meetings

Jacksonville, USA 15 December 2015 Fifth meeting. The Management Committee of the International Pharmaceutical Regulators Forum (IPRF) met in Jacksonville, Florida, US, on 7 and 8 December 2015. Within the two and a half years after its establishment, the initiative has achieved substantial progress. In order to define the future direction, the Management Committee embarked on a strategy development process, which should be completed in June 2016. Fukuoka, Japan 8-9 June, 2015 Fourth meeting. The Managem...

3

IPRF – International Pharmaceutical Regulators Forum :: Members

https://www.i-p-r-f.org/en/members

The following organisations are participating in the meetings and activities of the IPRF. Regulatory Authorities and Agencies. Therapeutic Goods Administration (TGA). Brazilian Health Surveillance Agency (Anvisa). Portal.anvisa.gov.br. Health Products and Food Branch. The European Medicines Agency. Directorate-General for Health and Consumers (SANTE). Ministry of Health, Labour and Welfare. Pharmaceuticals and Medical Devices Agency. Ministry of Food and Drug Safety. Health Sciences Authority (HSA).

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IPRF – International Pharmaceutical Regulators Forum :: Working Groups

https://www.i-p-r-f.org/en/working-groups

One of the objectives of the IPRF is to identify the need for harmonization or regulatory convergence, as well as for regulatory cooperation, including work-sharing, in specific areas. Several working groups are already in operation:. Cell Therapy Working Group. Gene Therapy Working Group. The Good Clinical Practices (ICH E6) Working Group completed its mandate in November 2014. Good Clinical Practices Working Group. International Pharmaceutical Regulators Forum.

5

IPRF – International Pharmaceutical Regulators Forum :: Purpose

https://www.i-p-r-f.org/en/iprf-network

The Regulators Forum was originally created as a safe harbor for discussion and promotion of harmonization among regulatory authorities and Regional Harmonization Initiatives (RHIs), hereafter referred to as members . The Regulators Forum has evolved to the point of needing a more formal structure and the following Terms of Reference were created to provide for future activities. International Pharmaceutical Regulators Forum.

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Drugs, Biologics, Medical Devices | Global Regulatory, Commercial, Reimbursement News | RegLink Breaking News

http://www.reglinknews.com/reglink_breaking_news.html

Sample Medical Device Update. This Week's Breaking News. Advisory Board and Expert Network. Free 30-DAY Global Update Trial. China announces 10-point drug reform program. CFDA has issued a bulletin. 11 drugs by 8 companies denied approval due to fraud. China’s FDA has denied. On-site GMP inspection guidance issued for local agencies. CFDA has issued a notice. To local regulatory agencies with specific guidance on the conduct of on-site good manufacturing practices (GMP) compliance inspections of manufact...

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