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CDSCO introduces PSM system to discuss regulatory pathway for approval of clinical trial, new drug, medical devices, etc.
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Ramesh Shankar, Mumbai
January 30 , 2015
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The Central Drugs Standard Control Organisation (CDSCO) has introduced a
system of formal Pre-submission Meetings (PSM) of applicants with CDSCO
officers and subject experts to discuss regulatory pathway in respect
of specific application for approval of clinical trial, new drug,
medical devices, etc.
The system will facilitate to understand
the regulatory pathways required to be followed by the applicants for
approvals resulting in bringing transparency, accountability,
predictability and speedy disposal of cases.
According to the
CDSCO officials, the PSM system is being introduced by the CDSCO as
there has been demand from the stakeholders from time to time to create a
window for technical deliberations between stakeholders and regulators.
The
steps proposed to be followed by the applicants is that, first the
applicant has to request for PSM to CDSCO for approval of new drug,
clinical trial, medical devices, etc. Then the applicant will submit on
request the details of their proposal, fees for the meeting and
regulatory pathways proposed to be followed with justification keeping
in view the regulatory requirements as specified in Drugs and Cosmetics
Act and Rules.
After examination, the applicant will be informed
by CDSCO regarding the date and time for the meeting. The principle of
confidentiality will be maintained in such meetings. The agreed
regulatory pathways in respect of any application will be specific to
that application only and will not be applicable for any other
applications of the same applicant or any other applicant. The PSM is
not mandatory before submission of any application for approval of new
drug, clinical trial and medical devices, etc. The applicant is free to
submit such application even without any PSM. The detailed deliberation
will be held with the applicant keeping in view the regulatory as well
as scientific aspects relevant to the proposal.
The proceedings
will be recorded and minutes prepared will be duly signed by the CDSCO
officials, subject Experts and the applicants. One copy of the minutes
will be issued to the applicant for submission of their formal
application and further action as per the agreed regulatory pathways.
The regulatory pathways in respect of specific application will be
decided based on the presentation / information provided by the
applicant.
The CDSCO has invited suggestions from the stakeholders on this proposals by February 9, 2015.
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