Q1 & Q2 Sameness Requirements for Parenteral Generic Product Filings - US Vs EU

Q1 & Q2 Sameness Requirements for Parenteral Generic Product Filings -  US Vs EU

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

USFDA Guidance to Industry - Controlled Correspondence Related to Generic Drug Development

USFDA Guidance to Industry - ANDA Submissions – Refuse-to-Receive Standards

Procedure for marketing authorization – Chapter 1