How to accelerate PTE registration
One day in September I was driving and enjoying the colorful beautiful Yunnan landscape on the highway from Yuxi to Kunming with a friend who raised the question, why Chinese companies go EU for technical equivalence assessment but not USA, why people are used to talking about data compensation for EPA registration while talking about task force for EU. We started the topic and could not finish before arriving the Kunming airport.
For Registration and Renewal assessment, EU and EPA have the complete system and competences. It is close to 10 years since 1107/2009 implementation in EU, hundreds of active ingredients were renewed under 1107 and the conclusions in RAR (Renewal Assessment Report) are no longer so kind and favorable as used to be in DAR under old regulation. Carcinogenicity, mutagenicity, reproduction, PBT and endocrine disruptor, these critical criteria is getting rid of so many good performance active ingredients, Glufosinate, Diquat, Epoxiconazole (BTW not too many non-selective herbicides left available and we have to support Glyphosate otherwise). The neonicotinoids collapsed for bee issue. In contrast, Prothioconazole, the molecule not supported by Chinese ICAMA due to reproduction issue under Chinese Agriculture exposure scenario for female worker, and I always remember its restriction measure in EU due to aquatic organism toxicity that application should avoid runaway to the water, this time in renewal assessment it got high scores in various (eco) toxicological aspects, and likely to have a bright future in EU.
Back to complex Brazilian issues, did not remember when, Anvisa phase II evaluation started to follow the so called icy beauty EU Sanco 10597 principle. Complete Acute six and mutagenicity two is no longer a standard request and replaced by more scientific tiered approaches that based on phase I analysis result, QSAR, Ames and (others when considered needed), are requested accordingly, and alternative in-vitro test is preferable than in-vivo. Thinking about the Chinese new registration regulations, yes all the authorities are improving; life is getting better for us and the animals. BUT in Brazil still suffered from the big number of the queue for Technical Equivalence Process, so called PTE, more than 1000. What approaches can be done to accelerate PTE registration?
1. Manufacturer Inclusion. To sell technical to Brazil, firstly consider ADD SOURCE. Do not wait for own PTE;
2. To take advantage from others earlier submission and be picked up from the queue. This approach has been used by companies since 5-6 years before. Remember this is a free bus and we should treat the bus driver well and make him happy. Try to find a committed bus driver but not a fickle one;
3. Priority List. This is a high level approach mainly for formulated product. It does not say that the Technical cannot take advantage but very good knowledge for weeds, insects and diseases in the fields is needed, corresponding from the farm associations is needed, and better to have innovated formulation, imaging that the market had already three or more brands for one formulation, how can we ask the authority for one more priority?
4. MAPA had new approach since 2018 to speed up PTE with same dossier as previous approved one. The logic behind is similar with the RDC 184/17 as mentioned in previous article. The difference is this time we are talking about MAPA and CTA, not Anvisa and/or IBAMA. It has been only half years since the new approach and need more time to see the results in practice;
5. Last one to mention is a fresh hot news but without official announcement, maybe never,,, Recently MAPA evaluated all PTEs of one active ingredient from different applicants and sources. This looks amazing but may not a routine operation as far as my opinion; let’s wait for a while to check it out.
Client and Competition
The Brazilian companies are listed as Table 1 below according to their revenue level:
Taking Glufosinate-Ammonium as example, currently 3 brands (companies) in the market, and another 37 PTE process in the queue as Table 2 below,
Taking Table 2 data into Table 1 gives below Table 3, GREEN is the existing 3 brands (companies), YELLOW is PTEs in the queue,
1. Glufosinate is being registered by most of the generic company while seems not fitting into the portfolio of Nufarm, Ihara, Albaugh and Helm;
2. Dozens of formulation brands are coming in the future, giving opportunity for the manufacturers to be added as source, or a step forward with better position that be added as APPROVED PTE;
3. The players have to understand clearly the method of application and the target crops. What is the main application, burn down, post-harvest desiccation, overtop or spot application between the ridges? What is the target crop, soybean, maize, cotton or orchards?
4. Competition is tough. In the right column of Table 3 we can find applicants including Chinese manufacturers, Chinese traders and Indian companies. To survive, the manufacturers need excellent performance in manufacturing, the marketing companies need innovation in terms of method of application, extension of crop range and formulation type. Imagining, when the registration of a routine 200/g/L formulation is granted, and there are already 20+ same formulation but different brands in the market, how should I sell my product?