- 2 de julho de 2017
- Posted by: Assessoria Imprensa
- Category: Destaques, Mercado, Noticias
Já está disponível o Manual de Análise de Insumos Farmacêuticos Ativos (IFA) para orientar interessados e fabricantes sobre o registro de insumos. O manual é eletrônico e tem como objetivo principal uniformizar a análise do DMF (Arquivo Mestre da Droga, na sigla em inglês), que é um documento base sobre o registro de insumos farmacêuticos.
O insumo farmacêutico ativo é a substância que dá ao medicamento a sua característica farmacêutica. Ou seja o que faz com que um medicamento funcione.
Manual
A publicação traz um visual atraente, com estrutura em abas que facilitam a consulta. Para a sua elaboração foi considerada a legislação sanitária atual do país, o modelo de análise do International Generic Drug Regulators Programme (IGDRP), e a própria experiência acumulada pela Anvisa no Programa de Pré-Qualificação de Medicamentos da OMS.
O Manual de IFAs, também considera os guias das principais autoridades no mundo sobre o tema: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH); Agência Europeia de Medicamentos (EMA); Organização Mundial da Saúde (OMS); Diretoria Europeia para Qualidade de Medicamentos (EDQM) e a Agência de Saúde do Canadá.
O lançamento deste produto aconteceu no último dia 26 de julho pela Coordenação de Registro de Insumos Farmacêuticos Ativos (COIFA/GGMED).
Atualização contínua
Mesmo em processo contínuo de construção, o manual inova ao trazer ainda mais transparência ao procedimento de análise de registro de insumos farmacêuticos ativos (IFAs), além de ser mais uma ferramenta para agilizar os processos de trabalho na Anvisa, reduzindo o número de exigências técnicas e, consequentemente, o prazo de análise dos dossiês.
O processo regulatório das IFAs é complexo e por isso é importante que os solicitantes de registro de IFAs e fabricantes atuem de forma pró-ativa, dando acesso a documentação completa dos seus produtos.
O Manual de IFA está sujeito a atualização constante. Dúvidas, correções e sugestões podem ser enviada para o endereço coifa@anvisa.gov.br, por meio da associação que representa a empresa.
Acesse o manual: http://www20.anvisa.gov.br/coifa/index.html (Utilizar o navegador Google Chrome).
Com informações da Assessoria de Imprensa da Anvisa
Excellent post! We are linking to this great article on our website.
Keep up the good writing.
Excellent way of describing, and nice arrticle to obtain facts
on the topic of my presentation subject, which i amm going to deliver inn university.
Hurrah! Finally I got a webpage from where I can iin fact get
useful information regarding my study andd knowledge.
Hey there, You’ve done a great job. I wjll definitely digg it and personally suggest to mmy friends.
I am sure they will be benefited frm this website.
If youu are going for finest contents like myself, just visit this website everyday ass it offers feature contents,
thanks
With havin so much content and articles do you ever run into any issues of plagorism or
copyright infringement? My blog has a lot of completely unique content I’ve either written mmyself or outsourced buut it appears a lot of it is popping it up all over the internet without my authorization.
Do you know any methods to help stop content from being ripped off?
I’d truly appreciate it.
What’s up it’s me, I am also visiting this weeb page daily, this
web site is truly good and the users are genuinely sharig fastidius thoughts.
After exploring a handful of the articles on your site, I honerstly appreciate your way of
writing a blog. I book-marked iit to my bookmark webpage list
and will be checking back soon. Take a look at my web site as well andd tell
me how youu feel.
Have you ever thought about including a little bitt more than just your articles?
I mean, what you say is fundamental and all. However jut imgine iff
you added some great visuals or videos to give your posts
more, “pop”! Your conten is excellent but with images aand clips, this blog could definitely
be one of the best inn its niche. Amazing blog!
Everything is very open with a verry clear clarification of
thhe issues. It was truly informative. Your site iss very useful.
Many thanks for sharing!
Fantastic bezt ! I would like to apprentice at the samme
time as you amend your site, how can i subscribe for a
webhlog site? The account hhelped me a appropriate deal.
I have ben a littlee bit acquainted of thhis your brodcast
offered bright clear concept
Have you ever thought about writing aan ebook or guuest authoring
on other websites? I have a blog based on the same subjects you discuss and would
love to have you share some stories/information. I know my readers would value your work.
If you’re even remotely interested, feel free tto shoot me an e-mail.
Hi there, its pleasant paragraph on the topic of media print, wee all understand media is a
wonderful source of information.
Yoou ought tto take part in a contest for one of the finest sites on the internet.
I am going to highly recommend this website!
What’s up, foor all time i used to check web site
posts here in the early hours in the dawn, because i enjoy to ggain knowledge of more and
more.
Hey great blog! Does running a blog such as this take a lot of work?
I’ve virtually no expertise in coding however I waas hoping to start my own blog in thee near future.
Anyway, should you have any ideas or techniques for
new blog owners please share. I know this is off subject
nevertheless I just needed to ask. Cheers!
magnificent points altogether, you just gained a neww
reader. What may you recommend in regards to your submit that you just
made some days ago? Any positive?
Howdy! This is kind of off toppic but I need some help from an established blog.
Is iit difficult to set up your own blog? I’m not very techihcal but I caan figure
things out pretty fast. I’m thinking about setting up
my own but I’m not suree where to begin. Do you have any points or suggestions?
Thank you
Hiya! I know this iss kinda offf topic hwever I’d figured I’d ask.
Would you be interested iin trading links or maybe guiest writing a blog article or vice-versa?
My site discusses a lot of thhe saje subjects as yours and I feel we could greeatly benefit from
each other. If you happen to be interested feel free to send mee an email.
I look forward to hearing from you! Great blog by the way!
It’s an remarkable piece of writing in favor of all the web
users; they ill take advantage from it I am sure.
Thanks , I’ve recently beren searching for information about this subject for a long time and
youfs is the best I’ve found oout so far. But, what about thhe bottom line?
Are you positive in regards to the source?
This is the right blog for anyone who would like tto understand this topic.
You realize sso much its almost hard to argue with you (not that I actually will need to…HaHa).
You definitely put a brand new spin on a subject that has been written about for a long time.
Excellent stuff, just excellent!
Pretty section of content. I just stumbled upon your website and in accession capital to assert that I acquire actually enjoyed account your blog posts.
Anyway I’ll be subscribing to your feeds and even I achievement yoou access
consistently rapidly.
Everything is very open with a clear description of the challenges.
It was truly informative. Your site is very helpful.
Thanks for sharing!
No matter if some one searches for his essential thing, therefore he/she desires to be available that in detail, so that thingg is maintained over here.
It’s a pity you don’t have a donate button! I’d without a doubt donate to this outstanding blog!
I ssuppose for nnow i’ll settle for book-marking and
adding your RSS feed tto my Gogle account. I look forward to brand new updates
and will share this site with my Facebook group.
Chat soon!
Nice answers in returnn of this issue with genuine arhuments and
explaining everything concerning that.
Generally I do not read article on blogs, but I wish too say that this write-up very forced me
to take a look at and do it! Your writing taste hhas been surprised me.
Thanks, quite nice post.
Unquestionably consider that which you said. Your favourite justification appeared to be
oon the web the simplest factor to consider of. I say to you, I certaainly get annoyed while other people thinhk about
isdsues that thjey plainly don’t recognise about. Youu controlled to hit the
nail upon the top aand outlined out the whole thing with
no need side-effects , other people can take a signal.
Will probably be again to get more. Thanks
Hello to every single one,it’s really a pleasant for me to pay a quick
visit this web page, it contains valuable Information.
always i used to read smaller content that also clear their motive, and that is also happening with this paragraph which I am reading att this time.
Please let me know if you’re looking for a writer for your site.
You have some really good articles and I think I
woud be a good asset. If you ever want to take some of the load off, I’d really like to writee some content for your blog in exchange forr a link back to mine.
Please blast me an e-mail if interested. Cheers!
I am really delighted to read this webpage posts which carries plenty of helpful data, thanks for providing these information.