加拿大仿制药注册量上升

Jillian Bender 是 CropLife Canada 的通讯官,讨论了加拿大作物保护行业的状况。

1. What factors are affecting Canada’s crop protection industry?
2010 年和 2011 年,加拿大西部因洪水而大面积未种植,这对作物保护产品的销售产生了重大影响。预计 2012 年销售额将以相对温和的方式复苏。加拿大仿制药的注册量也有所增加。

There continues to be good growth in biotech seed sales, which is expected to continue. Consumer acceptance is a challenge that impacts Canada’s exports markets, particularly in places like Europe that have yet to embrace plant biotechnology despite internationally accepted science that demonstrates its safety and the benefits it can deliver.

2. 是否有影响行业的立法问题?
加拿大和美国在通过北美自由贸易协定和经合组织实现农药法规国际协调方面发挥了重要作用,种植者通过监管合作委员会倡议从中受益。我们希望在注册同一产品时,边界两边都能看到更快、更可预测的审批流程。

加拿大的植物生物技术法规已经过时,并且难以跟上瞬息万变的形势。这一点,再加上监管人员和专业知识的数量有限,导致新植物生物技术特性的批准时间更长。

3. 该国是否正在进行任何研发?
Internationally, the plant science industry reinvests 11% of its total sales into R&D. With public sector funding for R&D declining, private-sector investment continues to be important along with greater reliance on public-private partnerships. Canada is joining the international research community in advancing its understanding of the complex and unique genetics of one of the world’s most important crops: wheat. Canada will contribute to the improvement of wheat varieties, which have lagged behind advances made by other staple crops.

4. How is glyphosate resistance affecting Canada’s agriculture industry?
This is a relatively small issue in Canada compared to what’s happening in the US. Only a handful of resistant weeds have been identified here in Canada. The industry is taking a number of steps to mitigate herbicide resistance. New herbicide-resistant crops are currently in development, which will offer farmers greater choice and variety. The industry is also enhancing its communication with growers to raise awareness about the importance of proper rotation and agronomic practices.