E-drug: Request for Assistance/Survey/Drug Registration
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[Please forward response to wak@bu.edu NOT to e-drug. BS]
Dear Colleague(s):
The Boston University School of Public Health (Boston, Massachusetts
USA) in conjunction with Management Sciences for Health, is studying global
regulation and registration of pharmaceuticals and we are asking members of
Drug Regulatory Authorities to please take a few minutes and participate in
the attached survey, which also includes contact information.
An electronically-transmitted response sent no later than 31 March 2002
would be most useful and greatly advance our knowledge of drug regulatory
practices around the world. Your assistance is appreciated.
If you can respond, please e mail the completed questionnaire to us at
wak@bu.edu.
Richard Laing, MD, MBChB, MSc
Boston University School of Public Health
Warren Kaplan, Ph.D., Esq.
Boston University School of Public Health
715 Albany Street, T-4W
Boston, MA 02118
1. Please indicate the governmental fees for initial registration,
maintenance of registration, and renewal of registration for the following
:
IN US DOLLARS OR LOCAL CURRENCY
Market authorization (new chemical entity)
INITIAL FEE________
MAINTENANCE FEE_____
RENEWAL FEE_____
Market authorization (multisource/generic entity):
INITIAL FEE____
MAINTENANCE FEE_____
RENEWAL FEE___
Manufacturing facility inspections for new chemical entity manufacture
INITIAL FEE____
MAINTENANCE FEE_____
RENEWAL FEE_______
_________There are no manufacturing facilities of this type in our country
Manufacturing facility inspections for multisource (generic) manufacture
INITIAL FEE____
MAINTENANCE FEE_____
RENEWAL FEE___
________ There are no manufacturing facilities of this type in our country
Inspection and validation of dispensing facility
INITIAL FEE____
MAINTENANCE FEE_____
RENEWAL FEE___
2. Please indicate the average duration (in months) of your pre-marketing
approval process from initial filing of sponsor's dossier to registration,
for those initial filings between:
1990-1994: ________________
1995-1999: _______________
2000- 2002: ______________
3. Please indicate on the following table the number of new chemical
entities and generic products approved by your Authority for the stated time
periods:
Chemical 1995 1996
1997 1998 1999 2000 2001
NEW CHEMICAL ENTITY
MULTISOURCE (GENERIC)
4. Are there "fast track" or expedited approval process in place:
Yes_________ No____________
If yes, what drugs would quality for expedited approval?