AgroPages-Brazil 2007 registration advance-Agricultural news

Brazil cleared up a large part of its backlog of pesticide registration applications in 2007. The build-up of all requests fell by 81.4% in the first 11 months of the year to 250, executive director Tulio Oliveira of Brazil's generic industry association, the AENDA, told Agrow. The figure includes applications for research, registrations requiring a complete dossier on an active ingredient, generic ai equivalency and formulated product approvals. The Brazilian Agriculture Ministry's chamber of agricultural inputs, the CTIA, reviewed progress on the registration process at a meeting with industry and approval body representatives in December. The annual review was the first since Decree 5981 on speeding up registrations came into force in December 2006.

"There was significant progress," Mr Oliveira says. The backlog of requests at the start of 2007 included 836 research applications, some 71 ais under the equivalency system, a further 36 that required a full dossier, and 339 formulated products. Despite new applications during the year, the backlog of ais to be assessed under the equivalency system fell by 39.4% by the end of November, while outstanding applications requiring a complete dossier were down by just over half. Only 59 research and 55 formulated product applications were unresolved by the same date.

Brazil registration performance January November 2007

Jan 1st 07 2007 Nov 30th 07

Applications backlog applications backlog

Research 836 675 59

New ais 10 5 0

Other full

dossier 36 6 17

Equivalency ais 71 63 43

Formulated

products 339 130 55

TOTAL1 1,576 1,238 250

1 includes applications containing alterations, such as

transferring registrations to a third party and additional crop

field tests. Source: Ministry of Agriculture via the Aenda.

The President's Ministry, the Casa Civil, is to focus on the length of the approval process in 2008, Mr Oliveira says. It aims to contract more personnel, clarify procedures and improve communication among the "task force's" registration bodies. They are: the Ministry of Agriculture; the Brazilian environmental institute, the IBAMA, which considers environmental aspects; and the national health surveillance agency, the ANVISA, which covers toxicological matters. The aim is to have a maximum 150-day approval process.