农业综合企业非常熟悉世界各国的农用化学品监管流程。另一方面，审查和批准生物制品的过程可以使用一个新的视角。为用于审查生物制品的农用化学品创建的监管框架可能会造成积压并阻止新技术进入市场。我们与 AgBioScout 的首席科学官、生物控制专家 Roma Gwynn 进行了交谈，以了解她在世界各地看到的调节微生物和植物药的方法。
ABG：生物制品的监管变化是什么？
回复： When new biological technologies are getting submitted for regulation review, they are required to fit into the existing regulatory framework, which is designed for conventional chemicals. The problem is that the types of substances biologicals are made up of don’t fit within that regulatory framework. The wrong questions are being asked, and the right questions are not being asked.
There has been a lot of activity and development in biological technologies. It’s recognized that regulation can be a barrier to the adoption of these new technologies. Lack of specific regulation is slowing down the innovation that’s going on. No one wants to compromise safety in any way, but there’s a need to change the system so that it’s appropriate, proportional, and better resourced with evaluators with the right skills.
ABG：哪些国家/地区在制定生物制品法规方面做得很好？
回复： 在过去的 30 年里，美国拥有一支精通生物技术的监管团队，其唯一的重点就是这些技术。由于这个团队，我们可以在美国看到比世界其他地方更多的可用技术。在巴西，他们致力于促进监管体系并使其更适合这些技术。由于这项工作，巴西现在拥有数量增长最快的可用生物制品。在肯尼亚，政府于 2003 年与合适的专家和利益相关者一起度过了一个周末，并修订了监管框架，从而缩短了监管审批时间并增加了市场上的产品。
There’s plenty of evidence from these countries to say if the regulatory changes happen it moves the new biological technologies into farmer’s hands at a faster rate. This benefits the health of people and the environment for achieving sustainability goals.
ABG：我注意到您没有提到欧盟 (EU)。他们在监管过程中的表现如何？
回复： The EU is, in general, one of the slowest regulatory frameworks that we have both for chemicals and biologicals. The reason for that is a triplicate system, and it’s backlogged. It takes two years just to find a slot to submit your active substance for review, and then takes seven to 10 years to be evaluated and go from an active substance to product label. This is a massive barrier to new technology. It’s compounded for biologicals because only some of the EU countries are skilled in understanding and working with biological technology. Sweden, Denmark, Netherlands, and France for example have trained their regulatory staff to understand biological technologies, but this doesn’t reduce the review time, because of the volume of applications backlogged. The EU needs to resource its regulatory system properly to stop it holding back biological technologies.
ABG：监管过程对生物产业有何负面影响？
回复： 我们从不想在安全方面妥协，但监管阻碍了创新，因为它的适应速度不够快。生物防治技术已经存在多年，但政府一直没有采取任何措施来促进其进入市场。使一项新技术通过监管程序的成本约为 $500,000 至 $2 百万。对于任何一家公司，尤其是小型初创公司来说，他们都拿不到这笔钱。政府不为注册提供补助。我看到许多生物技术没有进入市场。这些初创公司无法在经济上为档案提供资金，然后不得不等待长达 5 到 10 年的时间而没有收入。另外，我见过大小公司拉动产品，因为他们既不能等待，也不能承担成本。与市场机会相比，注册成本太高。人们有一些伟大的想法，但由于监管的成本和时间而没有被创造出来。