What is Dossier?
It is collection of all the documents
which are necessary for filling a new product for marketing. Any regulatory
bodies of any particular country ask for the necessary documents which suffice
all the information about product.
What are the necessary documents and information for a good Dossier?
Dossier is country specific. Different
regulatory bodies have their own requirements. But in general, the basic
information and data are nearly same in each country. The document should be
sufficient to convince the regulatory bodies and able to provide all necessary
information to support the product.
a. Administrative information
b. References
c. Labeling
d. Drug product or drug substance,
literature references
e. Chemistry, manufacturing and controls (Basic information, product
development report, controls and critical parameters assessment, Quality
control and analytical method development and validation)
f. Non clinical data and
information (Pharmacology, Pharmacokinetics
Toxicology)
g. Packaging materials
h. Clinical data (Biopharmaceutic Studies and Associated
Analytical Methods, Clinical Pharmacology Studies, Clinical Efficacy, Clinical
Safety, Literature References, Synopses of Individual Studies)
i. Scale up and validation
report
j. Package information
leaflet
k. Regulatory status
Are those documents are uniform in all countries?
No. It depends on
the regulatory requirements of the particular country. Some regulated bodies
from USA, Europe , Canada, Australia has their own specific requirements
whereas countries like Nepal, India the basic information is necessary as per
the need.
Which is the language used in Dossier?
It again depends on
the country. Majority of countries expect the dossier in English but some of
the European, Latin American countries need dossier in their own language. Here
in Nepal, The regulatory bodies expect in English language.
How can I ensure that my dossier has all the information for the regulatory Bodies?
In major cases, the
information and data are in overall same but in same cases specially for
regulatory countries they have their own requirements. So, one has to go
thoroughly regarding the regulatory needs of a country.
Who can help us?
The regulatory bodies
can help you, or there are lots of companies working as third party
consulting firm. If you need for Nepali regulatory market, you can contact
pharmashastra team as well.
Read more about Difference between regulated and ROW
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