Sunday, 3 June 2012

GENERIC DRUGS FILING REQUIREMENTS - US VS EUROPE






GENERIC DRUG FILING REQUIREMENTS –
US VS EUROPE



A generic drug is identical--or bioequivalent--to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.  Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. 

Dossier for generic drug filling shall be submitted in the form of CTD in Europe, US & Japan. Generic Drugs are approved under ANDA (Abbreviated New Drug Application) in USA and MAA (Marketing Authorization Application) in Europe.





ABBREVIATED NEW DRUG APPLICATION - USA
New drugs, like other new products, are developed under patent protection.  The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect.  When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.  The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.  

An abbreviated new drug application contains data, which when submitted to FDA’s ‘Center for Drug evaluation and research’ (CDER), office of generic drugs, provides for review and ultimate approval of a generic product. Once approved, the applicant may manufacture and market generic drug product to provide a safe, effective, low cost alternative to American public.

Marketing Authorization Application (Europe)
In Europe drug approval process is regulated by European Agency for evaluation of medicinal products(EMEA),this agency gives Marketing authorization in European union.
Pharmaceutical companies can use 3  approval procedures to market their pharmaceuticals.
·       A centralized or
·       Decentralized or
·       Mutual Recognition

Centralized Procedure
Ø Allows a pharmaceutical company to market its pharmaceutical products in all 25 member states.
Applicant can submit single application to EMEA for marketing authorization that is valid to all member state. (Applicant need not to obtain separate approvals for each member state).
 
   Decentralized Procedure
Ø Using the decentralized procedure, manufacturer can apply for simultaneous authorization in more than one EU country, that have not yet been authorized in any EU country and that do not fall the mandatory scope of the centralized procedure.  

   Mutual Recognition Procedure
Ø In mutual recognition procedure, a medicine is first authorized in one EU member state, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other EU countries in a procedure where by the countries concerned agree to recognize the validity of the original, national marketing authorization.

COMPARISON OF REGULATORY REQUIREMENT BETWEEN US AND EUROPE


 Administrative
Requirement
US
EU
Application
ANDA
MAA
Approval time line
18 Month
12 Month
Copies
3,(archival,review,field)
1
Debarment Certification
Required
Not Required
Pharmacovigilance
Not Required
Required
Agent Authorization
Required
Not Required

Manufacturing And Control
Requirement
US
EU
No.of batches
1
3
Packaging
Minimum 1 lakh units
Not required
Process Validation
Not required at the time of submission
Required if it is MR formulation or aseptic product
      
Finished Product  Control
Requirement
US
EU
Assay
90 -100 %
95 -105 %
Identification Test
Single Test
Additional test required
Colour Identification
Not Required
Required
Water Content
Required
Not Required
Disintegration Test
Not Required
Required

Labeling Requirement
Requirement
US
EU
NDC No.
Required
(10 digit)
  Not Required     
Prescription Status
Rx
POM
Labels
Vials/Carton/PIL
Vials/Cartons/PIL/SPC
Side by side comparison
Vials/Carton/PIL
Not Required
Readability Testing
Not Required
Required

Bioequivalence  Requirement
Requirement
US
EU
No.of batches
1
         2
Date and time of submission
3 Month accelerated and 3 month log term
6 Month accelerated and 6 month log term
Container orientation
Inverted and upright
Do not addressed






10 comments:

  1. Excellent blog very nice and unique information related to GENERIC DRUGS. Thanks for sharing this information.
    generic drug manufacturer

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  2. Generic drugs recipients include binders and lubricants to make efficient tabletting. Generic drugs presented with cleanness, accurate structure and no complications. Generic drugs are provided with low cost and efficient products in market.

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  3. Very nicely compiled the difference in both the filings. Thank you for sharing this knowledge, (although we are aware we never tend to present it this way), just try to note the way it comes. This is a helpful way. Thanks again

    ReplyDelete
  4. very very nice blog, i like it, it was very informative and the comparison between us and Europe was awsome

    ReplyDelete
  5. Hi,
    Do you know is there a database similar to the Orange Book? I am trying to locate information for the EU reference listed product but was not able to find it.

    thanks!

    ReplyDelete
  6. Really its good and informative.....

    ReplyDelete
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