ISPE Invites Your Comments

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As an ISPE Member, you can participate in the creation of science-based regulations and guidelines.

As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE is the neutral organization through which industry and global health organizations collaborate to improve product quality and patient health.

When ISPE plans to comment on a new or revised regulation or guidance, invitations to submit comments are sent to Members of relevant COPs and posted below. Prior to submission, the comments are vetted by industry SMEs and/or the Regulatory and Compliance Committee (RCC), and ISPE Regulatory Advisors.

Current Commenting Opportunities

ISPE invites comments on the following:

Regulatory Body Document Comments due to ISPE
US FDA Draft Guidance for Industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification 8 July
EMA Guideline on Process Validation for the Manufacture of Biotechnology-derived Active Substances and Data to be provided in the Regulatory Submission 22 August

FDA draft Guidance for Industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

The draft Guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product.

This draft Guidance:

  • identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain;
  • provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable;
  • for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA.

Please submit comments to ISPE by 8 July 2014 using the commenting form provided below.

Email the commenting form to regulatorycomments@ispe.org

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EMA draft Guideline on Process Validation for the Manufacture of Biotechnology-derived Active Substances and Data to be provided in the Regulatory Submission

The draft Guideline provides guidance on data requirements for process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. This Guideline covers process evaluation and verification studies for the upstream and downstream process, in the context of a marketing authorization application or a variation application if relevant. The Guideline also determines the validation data to be submitted as part of an application for marketing authorization or variation of an existing authorization for a medicinal product.

This Guideline applies to recombinant proteins and polypeptides, their derivatives, and products of which they are components and other biological products such as vaccines or blood products, as appropriate.

Please submit comments to ISPE by 22 August 2014 using the commenting form provided below.

Email the commenting form to regulatorycomments@ispe.org

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Last Update: 05 June 2013

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