Things you must know about Medical Device Registration India and Pharma CTD dossier
by Varsha Gaur teacherIf
an individual wants to introduce a new medical
device regulation india
or
wish to manufacture any regulated device, then it is required by the individual
to abide by medical device rules (MDR, 2017). In this article, we will discuss
the medical device regulations and the importance of Pharma CTD dossier for
drug regulation.
After the publication of MDR 2017, the government
of India has finally released some clearly defined rules for a medical device in India
that came into effect from January 1, 2018.
Let's have a
look at some of the important points for medical device regulation. These rules
are applicable in respect of :
· substances
used for in vitro diagnosis and surgical dressings, surgical bandages, surgical
staples, surgical sutures, ligatures, blood, and blood component collection bag
with or without anticoagulant covered under sub-clause (i);
· substances
including mechanical contraceptives (condoms, intrauterine devices, tubal
rings), disinfectants and insecticides notified under sub-clause (ii); and
· devices
notified from time to time under sub-clause (iv)of clause (b) of section 3 of
the Drugs and Cosmetics Act, 1940 (23 of 1940).
Now
coming to the dossier, you must know what is Dossier?
The
word “Dossier” has its English meaning as - a collection or file of documents
on the same subject, especially a file containing detailed information about the person or a topic.
Registration
Dossier” of the pharmaceutical product is a document that contains all the
technical data (administrative, quality, nonclinical and clinical) of a
pharmaceutical product to be approved/registered/ marketed in a country
Pharma
CTD dossier is one of the best choices of the
healthcare industry for controlling regulatory affairs services in India. It
provides assistance on various regulatory aspects in the pharmaceutical industry
and all other industries where regulations are consistently undergoing
evolution. The CTD format influences the content of the review by imposing a consistent order of information and data. This shapes both the conduct of the
review and the presentation of the results of the review and promotes good
review practices and increased efficiencies.
This
ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common
format for the preparation of a well-structured Common Technical Dossier (CTD)
applications that will be submitted to ASEAN regulatory authorities for the
registration of pharmaceuticals for human use.ACTD
Dossier compliance helps a lot in the
documentation of Pharma regulatory services. In addition to that the regulatory
affairs, laboratory classification, regulatory affairs consultation product,
medical and lingual translation, advertisement approvals, manufacturer
registration and product registration are well taken care of.
The pharmaceutical industry is vast and extends to a greater extent in the world.
The drug regulatory agencies need Pharma CTD dossier to get the approval for
drug marketing. The Pharma dossier consists of varied documents that represent
the number of research years. These researches involve multi-discipline
information about safety and drug efficiency.
Management of Pharma CTD Dossier
The
regulatory process and the dossier submission require several communications
between the company that approaches for submission and the regulatory authority.
This is the reason, why the effort of gathering the documents and then
presenting in a compliant format depends on the sponsor's shoulders. The whole
process is very complicated that requires high costs and needs management of various
components and documents during the process of approval.
Thus,
we can say that pharmaceutical dossier is one of the detailed documents of drugs
that need exclusive data on several aspects. The compilation of data needs
various skills of sourcing, interpreting and document writing. The whole
process of Pharma dossier requires an expert team of a data analyst, pharmacist
as well as research assistants. It is time taking as well as expensive. So,
it's better to shoulder this responsibility on Consultants who have expertise
in Dossier Compilation and submission.
Conclusion:
Thus, it is concluded that it is out most important to follow rules and
regulation before introducing any new product in the market.
Sponsor Ads
Created on Jun 21st 2019 06:37. Viewed 417 times.