Guys

I am looking for listed below following answers please help me out if you could

When is the time to apply for new Manufacturing facility Certification? At what stage of facility development?

b. Does product registration and certification go together?

c. What time line for approval from the application date?

d. What are the steps of product registration? What costs are involved in product registration? What is approx total cost of one product registration?

Thnaks in advance

a. the FDA term is establishment registration and should occur when relevant activities are occuring there
b The FDA term for product registration is device listing and you will be asked to cite devices connected to the establishment.
c. Not sure what you mean by product approval; for a class II device this could be 510K marketing clearance, for a class III device this could mean premarket approval.
d. Your questions are very broad and difficult to be answered responsibly here. The best thing for you to do is visit the Device advice page of the FDA website

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

Start with Overview of Device Regulation and drill on down. This is an excellent starting point. Good Luck. Rich

if your questions are about drug manufacturing, this would be a good place to start,

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm

Thanks for your respose but this question in regards to start up of new Generic pharmaceutical company or business When is the time to apply for start up site CERTIFICATION? AT wHAT STAGE FACILITY DEVELOPMENT? Does ANDA registration and site certification go together? What is the filling cost for ANDA? WHAT is the waiting time to get approval for ANDA? What are steps for ANDA registration?

tHANKS IN ADVANCE

Please any body post answered

Perhaps I'm wrong, but your questions seem to imply that you aren't particularly familiar with FDA pharma regulation yet.

If you're responsible for a pharma facility's quality and regulatory compliance, you need to be totally familiar with FDA pharma regulation.

The link in Gar4guv's post above is where you should start. Once you've studied all of the sublinked guidances and documents, and all of the guidances and documents that are linked from those sublinks, your questions will already be answered.

Please any body post answeredRelax! It's a summer weekend in the USA - most folks who are knowledgeable enough to give you a good answer are off enjoying a recreational weekend following a long, hard work week.

It would also be good to know the circumstances surrounding your request and the real urgency in getting answers.


Where is the plant to be located?
One product to be produced or many?
Well-financed or shoestring operation?
Approximately what size and scope of operation?
Is the manufacturing equipment already selected or yet to be determined?
Chemists, pharmacists, and engineers on staff already or yet to be selected?

First, some US/FDA terminology:
Generic drugs are approved, not registered, via review and approval of the Abbreviated New Drug Application (ANDA)
Establishments involved in the manufacture, preparation, propagation, compounding, or processing of drugs must be registered within 5 days after submitting a marketing application.
An approved drug must be listed with FDA before it can be commercially available in the US.

ANDA submission and approval, establishment registration, and drug listing don’t HAVE to “go together”; however, they are done in a certain order, since one step leads to the next, with commercial distribution being the ultimate endpoint. In my experience, here’s how it usually/often works in practice for a simple case in which a sponsor with a soon-to-be filed marketing application produces (manufactures, tests, packages, etc.) the drug in its own facility, and the facility has never been registered with FDA:

When a sponsor is close to filing its ANDA (this also holds true for NDAs), it registers the establishment and obtains a registration number, which must be included in the ANDA. The ANDA is then submitted, and approval takes 6 to 20 months (more or less, depending on the quality of the submission, FDA’s workload, legal stays, etc. The last I checked it, about a year ago, I think that the average review time for an ANDA was about 17 months, but most of the ones that I’ve worked on have been much faster.) When the ANDA is approved, the sponsor then lists the drug with FDA, in preparation for product launch.

You can submit your establishment registration any time prior to or up to 5 days after submitting an ANDA, put there isn’t any regulatory reason to register well before the filing of a marketing application. You can’t list your drug until it is approved, so therefore drug listing is done any time after ANDA approval and before commercial distribution.

As of now, there is no filing fee for ANDAs (unlike NDAs or medical device applications), but that might change in the next year or two.

Two points that might be of use/interest to you:
1. As of this past summer, you must register/list via FDA’s on-line electornic gateway, and submit using SPL.

2. If you’re a foreign establishment, you’ll need a US agent for establishment registration and listing. You'll also need an attorney, agent, or other authorized official who resides or maintains a place of business within the US to sign the application form that accompanies the ANDA - this doesn't have to be the same person used for establishment registration and listing, but it can be.

Now on to the hardest topic: what is required for ANDA approval? I second the recommendation by a previous responder - start out reading about the subject on FDA's website. And even then, unless you are knowledgeable about drug development and FDA's expectations, you should consider hiring in, or working with a partner or consultant, who understands the requirements. As for cost - it depends on so many things, including exactly what cost you're referring to. Cost for the entire development, including all facility, product CMC, Biopharm, and regulatory costs, or just the cost of compiling the document? Is this a simple molecule? Will bioequivalence be easy to show? Etc...As with most things, knowing the specifics makes all the difference. And even then, I don't think that anyone can give you more than a hugely broad range, in a forum venue.


Good luck!

Thanks for your respose but this question in regards to start up of new Generic pharmaceutical company or business When is the time to apply for start up site CERTIFICATION? AT wHAT STAGE FACILITY DEVELOPMENT? Does ANDA registration and site certification go together? What is the filling cost for ANDA? WHAT is the waiting time to get approval for ANDA? What are steps for ANDA registration?

tHANKS IN ADVANCE

Firstly, I would like to know what stage are you at and would like to know if your organization is familiar at all with FDA regulations ?