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GENERIC DRUG
FILING REQUIREMENTS –
US VS EUROPE
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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.
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 4 approval procedures to market
their pharmaceuticals.
· A
centralized or
· Decentralized
or
· Mutual
Recognition
· National
Procedure
Centralized Procedure: The
centralised procedure allows the marketing of a medicine on the basis of a
single EU-wide assessment and marketing authorisation which is valid throughout
the EU. Pharmaceutical companies submit a single authorisation application to
EMA. The Agency’s Committee for Medicinal Products for Human Use (CHMP) or
Committee for Medicinal Products for Veterinary Use (CVMP) then carries out a
scientific assessment of the application and gives a recommendation to the
European Commission on whether or not to grant a marketing authorisation. Once
granted by the European Commission, the centralised marketing authorisation is
valid in all EU Member States.It Allows a pharmaceutical company to market its
pharmaceutical products in all 30 EEA countries (27 EU Member States plus Iceland,
Liechtenstein and Norway) (Applicant need not to obtain separate approvals for
each member state).
The use of the centrally authorised procedure is compulsory for most
innovative medicines, including medicines for rare diseases.
National Procedure: The
national procedure only one member state is involved. The documents submitted
to an authority are very specific to that particular authority and evaluation
of the application is carried out by the same member state. The evaluation time
for an application for a national marketing authorization is 210 days from the
receipt of the application.
When a company wants to authorise a medicine in several Member States, it
can use one of the following procedures:
Decentralised procedure: Where
companies can apply for the simultaneous authorisation of a medicine in more
than one EU Member State if it has not yet been authorised in any EU country
and does not fall within the scope of the centralised procedure.
Mutual-recognition procedure: Where companies that have a medicine authorised in one EU Member States
can apply for this authorisation to be recognised in other EU countries. This
process allows Member States to rely on each other’s scientific assessments.
COMPARISON OF REGULATORY REQUIREMENT BETWEEN US AND EUROPE
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Particulars
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US
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Europe
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General Information
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Regulatory Agency
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USFDA
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EMA
National
Agencies
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Application
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IND
NDA
ANDA
BLA
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MAA
[Article
8(3) Full Application, Article 10(1) Generic, Article 10(3)Hybrid(mixed)Application,
Article 10(4) Biosimilars, Article 10(a) well established use, Article 10(b)
Fixed combination products, Article 10(c) Informed consent/Duplicate]
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Registration Process
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One
Registration Process
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Multiple
Registration Process
Ø
Centralized Procedure (European Community)
Ø
Decentralized Procedure (Atleast 2 member states)
Ø
Mutual Recognition Procedure (Atleast 2 member states)
Ø
National Procedure (1 member states)
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Approval Timeline
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10
Months (Standard review)
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210
Days –CHMP opinion
Centralized
procedure 210+67(EC Decision: Granting/Refusing)=277 days
CHMP
Opinion (Ensure that medicinal
products have a positive risk - benefit balance in favour of
patients/users)
EC
Decision – Granting/Refusing
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Administrative Part
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Debarment Certification
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Applicable
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Not
Applicable
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Agent letter of appointment
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Applicable
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Not
Applicable
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Environmental
Assessment Report
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Applicable
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Applicable
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Pharmacovigilance
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Not
Applicable
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Applicable
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Specifying Medicinal product name in Braille format
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Not
Applicable
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Applicable
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Quality
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Number of batches
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3
batches
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3
batches
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Container closure DMF
Requirements
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Applicable
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Not
applicable
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API DMF Requirements
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DMF
(Type II)
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ASMF/CEP
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Number of API lots for Submission batches
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A minimum
of two lots of the drug substance should be used to prepare the three primary
batches of drug product.
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No
specific requirements
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Executed BMR
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Applicable
(Part of Dossier Filing)
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Not
part of Dossier filing
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Blank (Commercial ) BMR
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Applicable
(Part of Dossier Filing)
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Not part
of Dossier filing
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Stability Data Requirements
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Minimum
6 Month data – Accelerated, Long term & Intermediate (if applicable)
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Minimum
6 Month data – Accelerated, Long term & Intermediate (if applicable)
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Container orientation For primary batches of liquids,
solutions, semi-solids, and suspensions
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Product
should be place in worst case and non-worst case scenarios (Up right/Inverted
or Vertical/Horrizontal)
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No such
requirements
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Antimicrobial Effectiveness testing (AET) Requirements
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Applicable
(One Batch)
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Applicable
(One Batch)
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Special stability studies conducted to confirm the quality of
the constituted drug products (for example, parenterals and/or powders
reconstituted with diluents and/or drug admixtures)
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Applicable
(One Batch)
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Applicable
(One Batch)
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API DMF requirements
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Type
– II DMF
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CEP
ASMF
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Miscellaneous
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Initial Screening
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Applicable
(60 Days)
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Screening
will be done only for administrative part
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Fee Requirements
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Applicable
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Applicable
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Faster Approval Pathways
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Accelerated
Approval
Priority
Review
Fast
Track
Break
through Therapy
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Accelerated
Approval
Conditional
Marketing Authorization
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Goal Date
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Applicable
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Not
applicable
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Time Slot booking Requirements for dossier filing
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Not
Applicable
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Applicable
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Types of Queries
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IR/DRL/CRL
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Day 50/Day
100/Day 120/Day 180
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Key Words
eCTD requirements for US and EU
filings/Dossier, ANDA, MAA, EU, Mutual Recognition, Centralized procedure, Decentralized
procedure, National Procedure
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This post
is last updated on 6th April 2020)
