虽然达到监管协调的压力除了Covid-19之外，在全球外面都席卷了巴西健康监测机构（ANVISA），以适应国家的法规？
高级会议生产者丽贝卡布拉迪对...说Dr. Patricia Kott Tomazett，健康调节专家在Anvisa和毒品中的总体管理Dr. Darius-Jean Namdjou，Pharma公司Grunenthal的全球监管策略师，关于最近的发展原子能机构在毒品法规中实施。
该讨论强调了持续的挑战，制药公司在申请获得巴西批准的产品时可能仍然面临监管流程以及哪些领域正在改进。它还探讨了Anvisa最近的努力，与其他地区协调，并在寻求进入拉美市场时可以采取的可行战略。
The following transcript is an extract from the recorded discussion. You can watch the这里全面讨论.
Rebecca Brady：从行业的角度来看，你进入巴西的主要要求是什么？
namdjou：It’s also what’s common sense - 120 days is sometimes not enough for us, generally, because what we are seeing, I think, is something what’s observed in the industry, is that ANVISA’s very specific requirements of the CMC part of the dossier, analytical validation and these kinds of things which certainly can take a lot of time in case you need to repeat certain validations, so we go back to the lab, open up new methods and so on. We had one case where there was [a drug which had been approved] in Europe and we had to develop really a new method because we got the feedback in the registration process. ANVISA [said] ‘your method is not acceptable... and you really need to take it up from scratch'.
你知道这是很多努力。我们做到了，我们得到了批准，但这真的是在巴西制作产品的额外费用。到目前为止，关键挑战并不是临床部分，我认为还有其他机构可能更为重要，但我们也在会议上看到的是，安维萨对新物品的学习非常热衷于。We had, for example, very specific simulation methodology for some clinical trials... The feedback [from ANVISA] was ‘[it’s] not in our regulation yet - we can’t accept it now, but we can work together with you to make it acceptable’. I think that’s a very good approach in this sense. That is what I would say is a very specific thought of the agency from the industry point of view.
Rebecca Brady：Patricia，您可以在您的档案应用程序中以及如何通过破损问题与您交谈时，您可以添加任何您的Anvisa真正寻找的东西。
Kott Tomazett:Actually, what we are looking for is to implement the ICH guidelines as a member. We are working toward those guidelines [in] implementation, because we thought that this will help harmonisation and it would be good for the industry and for the agencies, not only for the international industry but also for nation industry. We are in the process, we are implementing guidelines, the CMC and efficacy and security guidelines, and we think that it will be very helpful. We are open for discussions, for new approaches. Our resolution for synthetic drug registration, the resolution 200, we are reviewing this resolution and we are talking about different pathways for synthetic drugs and I think the strategy of harmonisation will be a huge step for the industry.
Rebecca Brady：您认为下一步是达到全球协调的观点？工业可以做些什么来帮助这一过程？
namdjou：Possibly, I can share a concern on that. There is a concern that due to the COVID situation, some initiatives on the topic may be a little bit pushed back, because they may not have that priority, compared to COVID. Other than that, my big hope is actually that the digitalisation will help a lot around harmonisation as we are then more able to transfer the electronic dossiers and have real use for the same structure for these dossiers. There really may be some possibility to harmonise, and certainly where there’s already a lot of harmonisation ongoing, I know that Brazil is very active on that as a PIC/S member on the GMP area.
到目前为止，巴西要求为其他产品进行自己的检查，但可能没有权威，因为PIC / S [会员]也可能接受其他国家的某些检查，因为这也是该行业的大障碍在检查下有预约，所以安维萨必须来工厂，等等。这不是一个特定于巴西特定的项目，全球有很多国家将有一个设定的要求。俄罗斯只介绍了几年。所以这是与协调有希望的壮举之一。
,例如,有很多活动吗ongoing, is [in] the field of bi-equivalents. There’s a lot of global convergence activities. I think we are seeing already some fruits of these activities. It’s taking years because it’s a lot of political discussion and so on, but I think it’s trending [in] the right direction. I would not be able to really confer, let’s say, a timeframe until some items can be solved. The industry can help the associations to bring in information from other territories where certain states are already working to convince potential authorities on efficient process that could be implemented so I think that could be the main goal here, or the main input we could provide.
Kott Tomazett:I think industry, yes, can help harmonisation. It’s very important to work together - industry and the agencies. We receive a lot of questions from associations in Brazil. When we receive requests for meetings, for example, we accept. We do meetings with the associations and we accept all the feedback we receive. It’s positive, and we try to work with these questions and improve.
For example, about harmonisation, last year we implemented the ACTT guideline. It’s not mandatory yet, but we noticed this impacted a lot and we received a lot of questions and a lot of comments, and we are working [to] review the ACTT guideline because of this conversation between ANVISA and the industry and the associations. So I think working together is the key.
丽贝卡布拉迪: Is it important to first harmonise regions before aiming for the whole world? Do you agree with that being a good strategy, Darius?
namdjou：对我来说，显然是的，这将是一种非常好的方法，因为我们看到它肯定存在于欧洲。几十年来，我们也在欧洲，每个国家都有自己的监管，部分地互相矛盾等等，这使得行业非常努力。Even today we have topics where there’s no guidance available by the EMA, and there you can then see, if you go for meetings with authorities, you definitely get different opinions, different requirements, so for [the] development process that is very difficult to handle in the industry. And so definitely the organisations’ opportunity today to submit a product to EMA [and] have final assessments necessary [is] very very good.
I would also see certain cultural homogeneity, there are a lot of differences in Europe but also certain communities, and so I think there it was good to find some compromises and to be able to put up common rules at least for Europe. Here, a regional approach could be very helpful. For me, I certainly cannot judge how different the cultures are in LATAM, because for example, it has a different language already to most of the other countries, so may be quite different, but generalising could be a good approach.
Kott Tomazett:I think he’s right, there are a lot of differences between the Latin American countries. We have no agreement yet in the region, but in events, we think, [in] Latin America, there are always initiatives we talk about creating. This [is a] group requirement, but they’re not solid initiatives yet, but maybe it would be a good start. Although, our current steps are being ICH harmonisation because this is what we have for now. This is the step for now, this is what happens now. Our position in ICH, we thought that the discussions are global. These are the steps we are going through.
丽贝卡布拉迪: Where are the starting steps to get up-to-date information? Where should companies be going to get the information they need to prepare successful dossiers and successful regulation plans?
Kott Tomazett:In Brazil, for each class of drugs, we have specific resolutions. We have resolutions with the requirement for registration. We have a resolution for synthetic drugs, we have one resolution for biological products, biopharmaceuticals. So on ANVISA’s website, all this information [is] there in the drug page. Unfortunately there are only few [pieces of] information in English. This is very hard, but we are in touch with our international accessory, and this a request to translate the resolutions.
有一些解释的过程website for each drug class and we have a press office also when some resolution is revealed and published, we report as news on the website. In Portuguese, it’s so easy, but unfortunately there is a lot of work to translate the information. ANVISA’s website is a very good way to stay updated with regulatory information.