Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


GMP Requirement Guidance For Combination Products Satisfies Industry

Executive Summary

The guidance clarifies what constitutes a convenience kit, whether sponsors must submit GMP information in marketing applications and the applicability of combination product regulations to cross-labeled combination products.


Related Content

Quality Regulatory Updates In Brief: ICH, EMA, MHRA and FDA
Combo Product Consultations At US FDA May Suffer As They Become Formalized
FDA Issues Final Guideline On Combination Product GMPs
Device Industry Seeks More Clarity Following Combo Product GMP Final Rule


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts