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Regulations in Brazil: What the drug approval process is like in 2020

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While the pressure to achieve regulatory harmonisation has swept across the globe in addition to COVID-19, what has the Brazilian Health Surveillance Agency (ANVISA) been doing to adapt the country's regulations?

Senior conference producer Rebecca Brady spoke to Dr. Patricia Kott Tomazett, Health Regulation Specialist in the General Management of Drugs at ANVISA and Dr. Darius-Jean Namdjou, Global Regulatory Strategist at pharma company Grunenthal, about recent developments the agency has implemented in drug regulations.

The discussion highlighted ongoing challenges pharmaceutical companies may still face in regulatory processes when applying to get products approved in Brazil and what areas are improving. It also explored the recent efforts by ANVISA to harmonise with other regions, and actionable strategies which pharmaceutical companies can take when looking to enter the LATAM markets.

The following transcript is an extract from the recorded discussion. You can watch the full discussion here.

Rebecca Brady: From an industry point of view, what are the key requirements you have for going into Brazil, Darius?

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'.

You know that is a lot of effort. We did it, we got the approval, but that’s really something extra spent to make the product available in Brazil. The key challenge is not so much so far on the clinical part, I think there are other agencies which may be much more critical, but what we have seen, also in meetings, was that ANVISA is very keen on learning on the new items. 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, is there anything you can add to that about what ANVISA is really looking for in your dossier applications and when companies come and talk to you with breakage questions?

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: What do you think the next steps are to reach a point of global harmonisation? What can industry be doing to help that process?

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.

Until now, Brazil has a requirement to perform their own inspections for other products, but there may be no authority as a PIC/S [member] might also accept certain inspections by other countries because that also has been a big hurdle for the industry to have an appointment under inspection, so ANVISA has to come to the factory, and so on. That’s not a Brazil-specific item, there are lots of countries worldwide who would have a set requirement. Russia introduced it only a couple of years back. So that’s one of the feats which are hopeful with harmonisation.

Where, for example, there are a lot of initiatives 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.

Rebecca Brady: Is it important to first harmonise regions before aiming for the whole world? Do you agree with that being a good strategy, Darius?

Namdjou: For me, clearly yes, it would be a very good approach because we’ve seen very good presence of it certainly in Europe. Some decades back, we had also in Europe, every country had its own regulation, partly contradicting each other and so on, which was making it very hard for industry. 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.

Rebecca Brady: 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.

There are some explanations of the process on the 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.

Click here to watch the full discussion.

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