Insight 1: The importance of shaping regulatory strategy at the start of the product development process

Shaping a product’s regulatory strategy in the early stages of development gives 公司 the maximum flexibility in aligning the product’s technology, 市场营销要求, 和监管路径. It’s a cost-effective approach that makes it more likely that a 公司 will obtain regulatory approval to market a product sooner, as well as avoid costly disruption and potential adverse publicity down the line.

Often 公司 will develop products with the best intentions – whether that’s meeting the demand for devices to help with the COVID-19 public health crisis or producing products that are better for the planet. 然而,正如利记在线网址将发现的那样,这很容易违反规则.


The opportunity to help medical device 公司 shape their US FDA regulatory strategy during the early stages of development is what drew 劳里克拉克利记网址公司,JD, MPP. 副校长兼校长, 医疗器械监管, Laurie supports clients in achieving US FDA authorization in the most efficient way possible. “A regulatory strategy clearly sets out steps that need to be taken to reach the desired goal,”劳瑞解释说. “For many medical device 公司 that are launching products on the US market, this is obtaining FDA clearance for the proposed indication via 510(k) premarket notification. Taking a proactive and premeditated approach from the outset puts the 公司 in the driving seat. It can satisfy any existing FDA requirements for demonstrating that the type of device is substantially equivalent to another, 或者定义这些要求并将其应用到设备上. 获得正确的结果将使授权的路径更加精简.”

这些一般原则也适用于其他类型的产品. Understanding the potential impact of regulatory constraints from the outset helps de-risk the product development process and avoid costly mistakes.


The COVID-19 pandemic saw a dramatic rise in the number and type of disinfectant products placed on markets around the world. Many businesses rushed in to fill the increased demand for products that can kill viruses such as SARS-CoV-2 (the coronavirus) but did not stop to consider the regulatory implications. This was especially true of smaller 公司 that don’t have in-house regulatory teams. “Inexperienced 公司 can easily fail to identify that chemical products intended to kill or control microorganisms will typically meet the definition of a biocidal product under the BPR or an antimicrobial pesticide under FIFRA,解释说 艾米洞穴我是杀菌剂部门的负责人 & 化妆品. BPR是 杀生的产品监管 and applies in the EU and UK; FIFRA is the 联邦杀虫剂、杀真菌剂 & 灭鼠剂法 并且适用于美国.

在英国, 一家这样的企业开发了一个“消毒亭”, essentially a walk-through chamber that sprays people with disinfectant as they pass through. The 公司 claimed that the system reduced the risk of COVID-19 transmission by disinfecting users’ skin and clothes. 他们是否对这样的产品进行了尽职调查, they would have realized that the disinfectant spray is subject to the BPR and that the practice of spraying people with disinfectants is strongly advised against by public authorities, 如健康 & 安全主管(HSE), 联合王国政府SAGE委员会和世界卫生组织, who note that it could be harmful and is not effective at reducing the spread of the virus. 该企业受到HSE的强制行动, who required the product to be withdrawn from the market at a substantial cost to the 公司.

“Consulting with regulatory specialists such as 利记网址 at an early stage would have helped the 公司 avoid making such a costly mistake,”艾米说. “Our biocides experts have many years' experience advising 公司 a交叉 the UK, EU and North America on the permissibility of active substances in products, 安全使用要求, and regulatory obligations to help clients develop compliant products from ideation.”


Companies not appreciating the full scope of their regulatory obligations is something that 理查德主教高级化学物质 & 达到顾问,熟悉. 理查德刚从卫生部加入利记网址 & 安全主管(HSE),他曾是首席检查员, 负责达到的执行, 中电控股, 图片, 英国的生物杀菌剂和植物保护产品立法.

随着人们对可持续发展和保护地球的关注日益增加, a biodiesel manufacturer saw an opportunity to convert waste cooking oil from catering establishments to produce biodiesel for both heating and to fuel cars. 尽管该公司有回收废品的积极意图, their business model revolved around manufacturing a chemical substance from waste,”理查德解释说. “With no in-house expertise on chemicals regulations and no involvement from external specialist providers at an early stage, they failed to appreciate that they would attract registration duties under 达到.” 达到 有关注册的规例是什么, 评价, 授权, and Restriction of Chemicals in the EU and UK; and Article 5 means that businesses who fail to register substances cannot legally manufacture or place those substances on the market until they have been registered in full. “注册不是一个一蹴而就的过程. It’s complex and it took the 公司 many months to achieve 达到 compliance,”理查德解释说. “By involving regulatory specialists at an early stage of the product development process, they would have been able to identify their legal obligations and take action to comply, 从而避免了昂贵的中断.”

如这些例子所示, 公司 should not underestimate the importance of developing a robust regulatory strategy at the start of the innovation process. 它不仅会降低产品和工艺成本, it will facilitate a smoother authorization/registration process and reduce time to market.

If you have any questions about your own product’s regulatory strategy, do get in touch at info@m3mpolosuite.com