[e-drug] Request for Assistance/Survey/Drug Registration

["Warren Kaplan" <wak@bu.edu>]

E-drug: Request for Assistance/Survey/Drug Registration
---------------------------------------------

[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?
______________________________________________________
______________________________________________________
_______________________________________________________

5.  Do expedited approval procedures involve less expensive fees  or faster
registration times or both?
Fee: $__________
Speed of registration: ____________
Both: ________________________
Please explain:
_________________________________________________________
_________________________________________________________
_________________________________________________________
_________________________________________________________


6.  For drugs purchased by the government for the PUBLIC sector, what
registration requirements exist at the present time (PLEASE PICK ONE):

____  None

_______  Retrospective (after the purchasing order is placed with the
supplier)

________  Prospective (registration required before the government can
purchase the drug)


7.   Does your Authority have a Quality Assurance/Quality Control
laboratory?
Yes: _________

No: __________

If yes, what are the fees (US dollars) for a full pharmacopeal assay of:
Amoxicillin: $______________
Cotrimoxazole: $______________


8.   What are the regulatory/administrative mechanisms to receive Adverse
Event reports?
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________

9.  Does your Authority have responsibility for review of  package insert
information prior to marketing approval?

Yes: ____________

No: _____________

If No, who has this authority in your country? ______



10.   Does your Authority have responsibility for regulating advertising of
drugs?
Yes: ________

No: _________
If Yes, how is this done?

___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________


11.  Please indicate on the following table the number of new chemical
entities and generic products that have been recalled from the market for
the stated time periods:


Chemical                                            1995      1996
1997        1998     1999        2000   2001
NEW CHEMICAL ENTITY
MULTISOURCE (GENERIC)


12.  Is your Authority responsible for regulation/accreditation of personnel
such as pharmacists, pharmacist technicians and related staff?
Yes: ____________

No: ____________
If No, who has this responsibility?

If Yes, please provide the annual licensing  fees (US dollars)  for :
Pharmacists: $_________

Pharmacist technicians:  $_______________

Other pharmacy-related personnel: $_____________.


13.  Does your Authority have special regulations and procedures for:

Biotechnology-derived drugs:  Yes:__________    No: ___________

Herbal medicines:       Yes: _________  No: ____________


Thank you very much for your assistance. Please e mail your response to
wak@bu.edu
or send a facsimile to 617: 638-4476
  (Attn: Professor Richard Laing, Boston University
School of Public Health)



PaÌs/Country:____________________________________________
Nombre/Name:_________________________________________
TÌtulo/Title:______________________________________________
InstituciÛn/ Institution:_________________________________
InstituciÛn/ Institution:____________________________________
DirecciÛn/ Address:_______________________________________
DirecciÛn/ Address:_______________________________________
Telex: ___ ______________________________________________
Fax: ___________________________________________________
Tel: __________________________________________________
E-Mail : ________________________________________________
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