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IGBA applauds long-awaited scientific harmonization process of bioequivalence studies (December 2019)

The International Generic and Biosimilar Medicines Association (IGBA) welcomes the adoption by the International Council for Harmonization (ICH) of a new topic proposal on Bioequivalence for ImmediateRelease Solid Oral Dosage Forms (M13)i . The ICH Assembly approved the Concept Paper Outline in their November Singapore meeting with the establishment without delay of a new Working Group to initiate work on finalizing the concept paper and business plan for this new topic.

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IGBA Statement on Hosting of Pat-INFORMED by WIPO (December 2019)

Since September 2018 the World Intellectual Property Organization (WIPO) has hosted the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) patent database Pat-INFORMEDi on its website. This database is simply a posting of unverified patent information provided directly by originator pharmaceutical companies. WIPO specifically exempts itself and IFPMA member companies from any and all liability for the provision of false or inaccurate informationii .

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WHO signs MoU with International Generic and Biosimilar Medicines Association to promote access (October 2019)

Full access to medicines is hampered by a variety of factors. Two important barriers are high prices and regulatory issues such as long lag times in bringing medicines to market.

Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

c/o Interexperts SA
Rue des Pierres-du-Niton 17
1207 Geneva, Switzerland

Telephone: +32 (0)2 5346607
E-mails: 
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