Search Results for ANVISA

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BIO Highlights IP Challenges Around the Globe By Zachary Brennan - Published 07 August 2017

As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.

Categories: News, Africa, Asia, Middle East, Anvisa, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections

ICH Offers Updates on New Members, Progress on Guidelines By Zachary Brennan - Published 08 February 2017

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, Biologics and biotechnology, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANVISA, BIO, MFDS, CECMED, MCC, S11, GCP, regulatory guidance

FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants By Zachary Brennan - Published 14 October 2015

The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed.

Categories: News, Europe, Oceania, US, Anvisa, FDA, MHRA, TGA, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA, MHRA, ANVISA, Silimed, breast implants, particle contamination

Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics By Louise Zornoza, RegLink Associates - Published 04 June 2014

Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs. 

Categories: News, Latin America and Caribbean, Anvisa, Biologics and biotechnology, Generic drugs, Prescription drugs, Nutritional and dietary supplements, Submission and registration

Tags: Brazil, Anvisa, Registration, Renewal