INFO KGV | LIFE SCIENCES JANUARY 2020

ANVISA BEGINS PUBLIC CONSULTATION ON MEDICAL GASES

 

On 23 December 2019, the Brazilian Health Surveillance Agency (ANVISA) commenced Public Consultation CP No. 759/2019 (Portuguese Language), which proposes a Resolution on Good Distribution, Storage, Transportation and Dispensing Practices of medical gases.

Public Consultation No 759/2019 aims to remedy the current regulatory gap in the medical gases legal framework regarding distribution, storage, transportation and dispensing rules. These matters were not regulated by Resolution RDC No. 69/2008 when Good Manufacturing Practices were enacted. According to ANVISA, the new Resolution will mean that patients are supplied with products of higher quality.

Among other aspects, the proposed Resolution establishes:

• Quality assurance criteria related to the employees, company organization, documentation, conduct, trackability, patient complaints, recalls and returns of the products.

• Specific requirements for the stages of distribution, storage, transport and dispensation of medical gases.

Contribution forms for Public Consultation CP No. 759/2019 (Portuguese Language) are available for input until 2 March 2020.

 

ANVISA RELEASES PUBLIC CONSULTATION ON BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 2 January 2020, the Brazilian Health Surveillance Agency (ANVISA) released the Public Consultation No. 760/2019 (Portuguese Language) on drugs bioavailability and bioequivalence studies.

A bioavailability study is undertaken to determine the speed and extent of an active ingredient’s absorption into the bloodstream. Bioequivalence is demonstrated when two drugs have the same bioavailability. Once bioequivalence has been proved, the same clinical trial can be used for both drugs. This consequently reduces the complexity of the dossier on safety and efficacy during registration.

Public Consultation No 760/2019 provides a proposal for a Resolution that aims to update the requirements for conducting bioavailability and bioequivalence studies, which are currently established by a range of rules, including Resolution RE No. 1,170/2006 (Portuguese Language).

According to ANVISA, some of the key points set forth by the proposed regulation are the following:

• Inclusion of details on the conduct of adhesiveness and irritability studies for transdermal drugs.

• Drugs with a high variability shall have an extended acceptance range in relation to bioequivalence criteria.

• Drugs of narrow therapeutic index shall have a narrowing of the acceptance range regarding bioequivalence criteria as applied in other countries.

• Requests in relation to pharmacodynamic studies involving corticoids for topical use shall be submitted with bioavailability and bioequivalence studies.

Contributions forms for Public Consultation CP No. 760/2019 (Portuguese Language) are available for input until 7 April 2020.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”