New post-approval changes of drug products

On March 22, 2016, the Brazilian Health Authority (ANVISA) approved the amendments of Regulation RDC 48/2009, which refers to the post-approval changes of drug products. The amendments establish a new regulatory framework for post-approval changes through the incorporation of different risk analysis depending on the complexity and the health risk of the modified drugs.

Law 6.360 / 1976 establishes that products subject to health surveillance, such as drug products, cannot be marketed without previous approval by ANVISA, which analyses their safety and efficacy.

However, after approval, it is very common for companies to request amendments to the original features of a drug product at any stage of its life cycle, such as changes in its components and composition, the manufacturing site or the manufacturing process, among others. This post-approval process is also subjected to revision by ANVISA, since the requested modifications can potentially have an adverse effect on the identity, strength, quality, purity, or potency of a drug product, which may affect its safety or effectiveness.

It is expected that the new regulations will impact the number of post-approval requests currently pending in ANVISA, since they establish different types of analysis depending on the health risk that a post-approval change involves. Accordingly, ANVISA will focus on the analysis of post-approval changes that involve moderate or high health risks, whereas the approval of those having a lower health risk will be faster.

Source:  http://portal.anvisa.gov.br

Local Health authority signed a draft of cooperation agreement with El Salvador

The Brazilian National Health Surveillance Authority (Anvisa) signed a cooperation project with the Republic of El Salvador through the local regulatory agency for medicine, the National Directorate of Medicines (DNM – “Dirección Nacional de Medicamentos”) and the National Health Institute (INS – “Instituto Nacional de Salud”).

The cooperation project will strengthen the technical capacity of the regulatory authorities of El Salvador through the transfer of technological and regulatory expertise in pharmacovigilance, also known as drug safety. Price regulation, rational use of medicines, technology assessment and a laboratory tax analysis also will be a focus.

International cooperation promoted by Anvisa is one of the targets set in the strategic planning of the Agency, which aims to strengthen the regulatory capacity of countries in the region.

Source:  www.anvisa.gov.br

ANVISA improves timeframes for medical device market applications

According to an analysis of data from the Brazilian Health Surveillance Agency (ANVISA) performed the Medical Device Consulting EMERGO, Brazilian regulators for the medical device market have reduced timeframes in 2015 for responding to and processing submissions from registrants of some medical device market applications.

Throughout most of 2015, ANVISA was able to provide initial responses to 99 percent of market applicants within 90 days of submission. ANVISA’s success rate (90 days) applied mainly to new applications. In cases where the regulator requests additional information from Brazilian market applicants, the 90-day target response time once applicants provide additional information was met at lower percentages throughout 2015.

In terms of number of days it actually took ANVISA to respond to additional information provisions, the agency did perform better for most of 2015 than in previous years, but did not meet its 90-day target in any given month last year.

ANVISA also published data showing total numbers of medical device applications submitted to the agency over the course of 2015. The biggest category of submissions, “materials” that include implants, syringes and catheters saw a marked decline in volume.

Source:

http://www.emergogroup.com

http://portal.anvisa.gov.br

ANVISA has reduced the average authorization time by 165 days

According to the latest survey conducted by the Brazilian Health Surveillance Agency (ANVISA), the average time for any petition related to permits is 45 days. In September 2012 it was 210 days, so this is a reduction of 165 days.

The time reduction is the result of a series of actions taken by ANVISA over the past two years, including the use of computerized systems for the granting of Operating Permits (AFEs) of pharmacies and the simplification of rules for companies in a single standard published last year in the resolution RDC 16/2014.

In addition, a change in the Law 9.782 / 1999 also contributed to a large reduction of deadlines. The average terms for granting AFEs and Special Authorizations (EA) for companies, pharmacies and drugstores fell by more than five months in the last two years.

The main objective of these measures taken by ANVISA is to optimize its workforce on the most relevant activities.

Source:  www.anvisa.gov.br

List of “clone” drug applications now available

The Brazilian Health Surveillance Agency (ANVISA) recently published a list of applications relating to the simplified procedure for the approval, post-approval and renewal of generic,similar, specific, dynamized (i.e. homeopathic) and phytotherapeutic(herbal) drugs, as well as biological products linked to the technical and clinical reports of a “mother” application (related to a “mother” or reference drug). This simplified procedure is referred to as a “clone” procedure.

On May 30, 2014, ANVISA published Resolution 31/2014 that revised the simplified “clone” procedures.According to the resolution, the clone drug must be of the same dose, form and presentation as the reference drug and it can only differ from it in the brand name, packaging layout and wording of the package insert and labeling.

According to Resolution 31/2014, ANVISA will approve a clone application with a mother application that contains all the technical and clinical information needed to request the approval of a reference drug, and also has been approved, provided it complies with the aforementioned requirements.

ANVISA reports that this list of applications will be updated monthly with the data obtained from ANVISA´s Registration System (Datavisa).

Clone applications awaiting analysis are divided into two lists: the first one includes applications where the “mother” application has no pending renewal, registration or amendments, and the second list comprises applications where the “mother” application is still pending analysis by ANVISA.

This simplified procedure is currently speeding up marketing authorizations for “clone” drugs in Brazil from months or years to a few days.

Source: http://portal.anvisa.gov.br

Change for the registration of cosmetics

On June 2, 2015, the Brazilian Health Surveillance Agency (ANVISA) published Decision 202/2015 changing the way of registration for cosmetics, personal care products and perfumes.Since June 15, 2015, the registration of these products must be done exclusively through the Agency Registration System (Datavisa), instead of the previous Electronic Automatic System (SGAS).

For cosmetics, personal care products and perfumes exempt from registration according to ANVISA Resolution 07/2015 of February 11, 2015, the registration should continue to be done at SGAS.

The owners of registers and post-registration applications for cosmetics, personal care products and perfumes filed through SGAS with test results that have not been yet published in the Official Gazette, should re-file the originally filed information.

ANVISA´s decision to return to the use of the previous registration system Datavisa was due to the identification of important inconsistencies in the SGAS and an effort to reduce the time of the registration process.

Source: http://portal.anvisa.gov.br

New regulations for clinical trials in Brazil

Aimed at speeding up the start of clinical trials for the development of new drugs and health products, Regulations RDC 09/2015 and 10/2015 were published on March 3, 2015, in the Official Gazette.

The new regulations, which revoke the previous RDC 39/08, take on a regulatory model in line with the main international health agencies regarding the submission of technical documentation and good clinical practice. They are also aimed at providing higher quality and administrative efficiency in the assessment of clinical tests by the Brazilian Health Authority (ANVISA).

One of the new features introduced by the regulations is the establishment of a fixed deadline for ANVISA to perform the evaluation of the drug clinical development dossiers (DCDD), which contain the projects of clinical trials to be performed in Brazil. This text containing the phase III clinical trials with synthetic drugs and carried out in other countries will now have to be reviewed by ANVISA in a maximum of 90 days.

This new rule also establishes that in those cases where ANVISA does not respond within 90 days, the study can be started, provided it has been approved by the authorities that assess the ethical aspects of the research. Requests for authorization currently awaiting technical evaluation and already in ANVISA prior to the validity of this regulation, also fall under this 90-day rule.

Phase I and II clinical trials with biological drugs or carried out only in Brazil, will have to be reviewed by ANVISA within 180 days. However,in this case the study cannot be started until it has been evaluated by the agency.

The new regulations seek to harmonize clinical trials in Brazil with other international standards and agencies. They are also aimed at encouraging the integration of Brazil in research that is carried out simultaneously in other countries.

These new regulations are the result of a public consultation carried out in 2014 among the Brazilian clinical research sector and, that received 641 contributions.

Source: http://portal.anvisa.gov.br