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Q1 & Q2
Sameness Requirements for Parenteral Generic Product Filings - US Vs EU
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Q1 & Q2 Sameness Requirements - US Market
In case of Parenteral
drug products, ANDA and RLD shall
have same qualitative and quantitative composition to active components and
generally must contain the same inactive ingredients and in the same
concentration as the RLD. However, specific changes (from the RLD drug product)
are permitted for certain inactive ingredients (i.e., preservatives, buffers,
and antioxidants), which are considered exception inactive ingredients.
Applicants should identify and characterize the differences and should submit
information demonstrating that the differences do not affect the safety or
efficacy of the proposed drug product. This justification is a critical aspect
of the exception inactive ingredient allowance and should be provided in the
ANDA to support the proposed exception inactive ingredient change.
For all other inactive ingredients, an ANDA whose
subject is a parenteral drug product must be qualitatively and quantitatively
the same (Q1/Q2 same) as the RLD, with certain allowable differences permitted
under 21 CFR 314.94. Before submitting an ANDA, the applicant can submit a
controlled correspondence to request a Q1/Q2 evaluation of proposed
formulations to minimize the risk of FDA refusing-to-receive the ANDA.
An ANDA concerning an ophthalmic drug product should be Q1/Q2 the same as the RLD with
respect to all of its components, or include data from appropriate BE studies. Despite
a similar allowance (to parenteral products) provided for ophthalmic drug
products in 21 CFR 314.94,FDA has determined that, as a scientific matter, any
qualitative or quantitative deviations from the RLD should be accompanied by an
appropriate in vivo BE study or studies.
For Otic drug
products, differences with respect to the types of inactive ingredients
listed in 21 CFR 314.94 are permitted, provided that these differences are
identified and characterized and information is submitted demonstrating that
these differences do not affect the safety or efficacy of the proposed drug
product.
Q1 & Q2 Sameness Requirements - EU Market
Generic and reference products shall have same qualitative and
quantitative composition only to active components and not to the other
ingredients of the product. However, difference in excipient composition or
differences in impurities must not lead to significant differences as regards
safety and efficacy.
Reference
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USFDA Guidance to Industry - Controlled
Correspondence Related to Generic Drug Development
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USFDA Guidance to Industry - ANDA
Submissions – Refuse-to-Receive Standards
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Procedure for marketing
authorization – Chapter 1
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