Bioequivalence and Bioavailability Forum

Thanks a lot Helmut for your reply

❝ ❝ Recently ANMAT issued a new document for consultation (ANMAT-MED-BIO-006-00, only in Spanish unfortunately) in which they reset bioequivalence requirements. If the document is approved, bioequivalence will be only required for products registered not longer than 5 years ago and for newly registered products. Older registered products would not require bioequivalence anymore.

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❝ I don’t understand the highlighted parts. The ANMAT’s BE-requirements (2006, amended 2007) are pretty detailed. Is it possible that a generic product was registered without demonstrating BE?

ANMAT regulatory requirements are crystal clear, also with several amendments made during the last few years, and are applied to newly registered products. However, according to ANMAT, complying with the BE regulations has somehow proven difficult for products already authorized and manufactured by the local pharma industry. This planned waiver of BE requirements is tailored to such products that lack a proper BE assessment and have been in the local market for more than 5 years.

❝ ❝ Are you guys aware of any agency that has ever issued such a regulation?

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❝ In the EU the market authorisation is initially valid for five years and becomes valid for an unlimited period upon renewal acc. to Regulation (EC) No 726/2004, Article 14, 1–3. See the Questions & Answers and linked documents. In the renewal procedure BE studies which lead to the MA generally (!) are not assessed again.

Thanks for the links. EMA, FDA and other LATAM agencies have set tight deadlines when introducing BE requirements for a given molecule, which affected all marketed authorized products that contain that molecule, irrespective of the date in which they have been authorized. According to this ANMAT proposal, if a product that lacks BE has been marketed in Argentina for more than 5 years before the new ruling, renewal of the marketing authorization would only require an in vitro head to head comparison of test and reference, and not anymore a proper BE study. To my knowledge there is no international precedent to such a ruling.