ISPE Invites Your Comments
ISPE invites its Members to comment on proposed regulations and guidance that affect the
Current Commenting Opportunities
EMA draft “Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the
Manufacture of Different Medicinal Products in Shared Facilities”
This guideline applies to all human and veterinary medicinal products, including investigational medicinal
products, and all active substances that are intended for manufacture in premises used for the manufacture of
other products or active substances.
The scope of the present guideline is to ensure the safety of human patients and target animals exposed to
residual active substances via medicinal products, as well as consumers potentially exposed to residual
active substances in products derived from treated food-producing animals.
This document aims to recommend an approach for deriving a scientifically based threshold value for
individual active substances to be applied for risk identification. This guideline also outlines how the data
on which the threshold value is derived should be presented in the risk assessment report in order to achieve
a clear and harmonious approach across pharmaceutical industry.
Please submit comments to ISPE by 10 May using the commenting form provided below.
Email the commenting form to firstname.lastname@example.org
- If the guidance is a revision to a current guidance, focus comments on the new items in the regulation/
guidance rather than on the existing sections that remain unchanged (applies to documents which have been
previously released by the agency). This is generally most relevant for EMA publications.
- Comments need to be meaningful and specific. For example, a comment of “This is stupid” does not meet the
criteria and will generally be eliminated from consideration.
- Meaningful comments need to include sound justification for the proposed change as well as specific
language that could be substituted for what the regulators propose.
- Be sure the justification and the proposed change are two separate items. Do NOT make regulators search
for the information and have to guess at your intent. Comments that do not include a valid justification and
proposed change will likely be omitted.
- If the incorrect grammar in a document could result in a misinterpretation of the requirements, then
please correct it. If not, and if there are many grammatical errors, a single suggestion that the “…grammar
should be reviewed and edited as necessary prior to issuance of the final document” is an appropriate comment
to be made one time.
- Identify either the line or section on which you are commenting. In most cases, the comment template will
provide guidance and structure.
- Write clearly and simply. Simple declarative sentences are good.
- When making reference to other regulations/guidance, be specific and provide the official title and
publication date where relevant either within the text or as a footnote.
- Avoid comparing the document under consideration to a similar one published by another regulatory
authority. While this is important to do internally within a company, it's generally not met with favor by
the regulatory authorities.
- Check and correct grammar, punctuation and spelling before submitting your comments. Your comments should
be publication-ready when you are done.
All comments received by ISPE are reviewed and consolidated by the Regulatory Compliance Committee (RCC).
The consolidated comments are then sent to the regulatory body by ISPE President and CEO and posted on the ISPE website. The names
of individual contributors are known to the RCC for the purpose of resolving differences of opinion among
contributors, however; the names are removed prior to submitting the comments to the authority and posting to
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Last Update: 25 February 2013