Lhasa Webinar on Industry perspective to meet M7, Q3A, RDC 53

Thanks @fernandaw for sharing about Lhasa Webinar next May 20th. Organized by LhasaWebinar. I couldn’t help notice RDC 53 as one of the topics on the agenda. Do we know where is Anvisa (Brazil) on Nitrosamines?
BTW @David from Lhasa shared with us several #KnowledgeNuggets in previous post.

@Naiffer_Host ANVISA published RDC 494 in April 2021 on Nitrosamine Impurities
RDC_494_2021_.pdf (193.7 KB)

RDC 494.pdf (431.6 KB)
Enclosed link provides a Regulatory update from Agencies in Latam on this subject.
A Summary of the Current Nitrosamine Medicinal Products Contamination Scenario in Europe, United States, and Latin America - updated 28th April, 2021 — Vita Regulatory Affairs Consulting.

@DAB those are wonderful resources. Thx.
This is specially important since several agencies are shaping the regulations and expectations. Wouldn’t be wonderul to invite them to be part of the knowledge and information exchnage taking place here in the community.
We have representation of several global organziation here in the community, interested to hear their perspective on this

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Hi Naiffer, I’m sorry that the webinar was mainly in Portuguese since it was more focused on RDC 53 which is a Brazilian regulation.
Anvisa has created a working group to discuss nitrosamines and they have shared a draft regulation and guidance with the industry. I believe the official regulation may be published later this year.


Hi DAB, thanks for sharing. This RDC is mainly a change to the previous RDC 283 which was specific for sartans. The old RDC required that from May 2021 the levels should be below 0.03 ppm, while this deadline has changed to December 2021 by the new RDC.
Nonetheless, the wider nitrosamines regulation that is being written by Anvisa`s WG will overturn this sartans regulation, since the WG understands that there is no need to eliminate nitrosamines to less than 0.03 ppm.


Hi @fernandaw Thanks for sharing the details.
Appreciate if you could share the guideline from ANVISA which is an English translation.
I do understand Portuguese but would appreciate an authentic English version of the Agency’s view.