Clinical and regulatory professionals are closely watching EU
Clinical Trial Regulation (EU-CTR) No 536/2014. This regulation was approved in
April 2014 on clinical trials on medicinal products for human use, and
repealing Directive 2001/20/EC. The application of the Regulation will occur in
May 2016, depending on timely development of the required IT by the EMA.
Important topic for labeling professionals is the content
of the labeling of the Investigational Medicinal Product (IMP) provided in EU
CTR 536/2014 annex VI.
This regulation introduces new term Auxiliary Medicinal
Products (AMP) instead of Non Investigational Medicinal Products (NIMP) and
also explains authorized and unauthorized AMP. Labeling requirements for
unauthorized AMP are also given in the regulation.
The correct labeling of an IMP or clinical trial label is
an important and integral part of the conduct of a clinical trial. The
labeling has implications not only for the safety and protection of the
subjects but also for the identification, traceability and adequate use of the
IMP as well as the identification and proper documentation of the clinical
trial. Regulatory requirements provide guidance and added value with respect to
these purposes.
So what it takes to review labeling contents against
regulatory guideline and local requirements?
Is it just to compare labeling contents versus list of
requirements in guideline? And mark the contents which are not added per
guideline? There is more to it......like review storage conditions per regional
requirements, check format of the sentence which gives critical information to
patients and review standard term usage of dosage form to mention a few.
Before regulatory review, one need to confirm if the trial
is blinded or open; If the primary and secondary packaging intended to remain
together and whether
product will be or not be taken home by the subject. Based on the confirmations
reviewer amends the contents.
Sometimes guidelines just give general direction, for
example it states “Particulars should appear in the official language(s) of the
country”. If the country has more than one official language it becomes tricky
in terms of compliance with regulations and requires local demographic
understanding, clinical trial requirements knowledge to reach the conclusion.
Local best practices and requirements are again reviewer
need to be updated with. Sometime local requirements do not have a foundation
of a guideline but do follow some best practices. Like in some Latin American
countries it is recommended to mention on label the term “Not for sale”.
IMP labeling is complex and companies need to face wide
range of requirements. They include regulatory compliance, regional language
and a quick and efficient manner to avoid disturbance to supply chain network.
If you would like to avail our regulatory services on IMP labeling
reviews for worldwide markets please contact us on suprabhanaralkar@iregconsulting.com
By: Suprabha Naralkar, Prinipal
Consultant, iReg Consulting LLP - See more at: http://regaffairspro.blogspot.in/
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