MA procedures two years after accession

1
MA procedures two years after accession

• Tzvetomir Deliyski
• Division Validation and procedure administration
• Bulgarian Drug Agency

2
Distribution of submitted MRPs, DCPs and NPs
between March 07 October 08

• Experience of BDA acting as CMS
• Validation phase
• Assessment phase
• National phase

• DCP 426
• MRP 190
• NP 159

3
Number of National MA, renewals and variations
for 20071 and 20082
4
Total number of DCPs MRPs from March 07 to
the end of 2007
5
Total number of DCPs MRPs from January 08 to
October 2008
6
The most common grounds for delaying the start of
a procedure (1)
7
The most common grounds for delaying the start of
procedures are (2)

• Missing/incorrect fee
• Missing letter of authorisation for communication
  on behalf of the applicant/MAH
• Missing originally signed declaration from the QP
  of the manufacturer/s responsible for batch
  release that the active substance is manufactured
  according GMP requirements and Braille
  declaration
• GMP certificates have not been updated or are
  missing
• Parts of Module 1 are missing or their absence is
  not justified (e.g. RMS, CTPG)

8
The most common grounds for delaying the start of
procedures are (3)

• DMF and/or letter of access to DMF is missing
• Application form/cover letter are not signed with
  original signature
• The submitted documentation cannot be identified
  (wrong number of the procedure etc.)

9
Legal base for DCPs between Mar - Dec 2007 (1)
10
Legal base for DCPs between Jan - Oct 2008 (1)
11
Legal base for MRPs between Mar - Dec 2007 (2)
12
Legal base for MRPs between Jan - Oct 2008 (2)
13
Distribution of MRPs DCPs by active substance
14
Referrals to CMDh in 2007 with BG as CMS

• 2 referrals to CMDh for MRP
• Products Generic
• Reasons Clinical safety and BE/BA between
  Referent Product and Generic Product

15
Referrals to CMDh in 2008 with BG as CMS

• Referrals to CMDh - 17
• 11 referrals for MRPs
• 2 referrals for Repeat Use Procedures
• 4 referrals for DCPs
• Reasons for referral to CMDh
• BE/BA 8 - SPC 1
• Clinical efficacy 5 - Clinical safety 1
• Quality 2

16
Total DCPs MRPs started between Apr 2007 Oct
2008 (1)
17
Delayed in national phase in DCPs MRPs between
Apr 2007 Oct 2008 (2)

• In 2008 there are 80 products both MRP and DCP
  waiting for an answer after assessment of the
  agreed SPC and PIL
• Granting of Marketing authorization is delayed
  due to missing local representative to handle
  national phase of the procedure.

18
The most common reasons for delaying the end of
the procedures from Apr 2007 to Oct 2008 (3)

• The authorized person for the national phase
  cannot fulfill the national requirements
  translation in Bulgarian language of agreed SPC
  and PIL, Cyrillic Braille alphabet
• Missing of a part of the fee due to change in tne
  national legislation

19
Technical preparedness of BDA for e-submission

• Electronic signature is in force since 2005
• Instalation of EiY
• EiY Validator NeeS Validator
• The main challenge in nearest future is
  connection to central repository in EMEA in order
  to obtain access to Centralized Procedures

20
E-submissions (eCTD) for MRP DCP currently
present
21
Bulgarian Drug Agency in the light of
e-submissions - main advantages

• Saving space
• High quality of scientific assessment
• Prompt access to all data for a particular
  medicinal product
• Continuous monitoring of a medicinal product

22
Reasons for failure of the eCTD / NeeS submission

• Delay / lack of communication between the local
  representative and the head office
• The contact persons for the procedure, based in
  Bulgaria are not trained to deal with technical
  issues during e-submissions
• Lack of financial resources and staff of applicant

23
National requirements for eCTD and NeeS
submission

• Originally signed
• - cover letter
• - application form
• - letter of authorisation for communication on
  behalf of the applicant/MAH
• - declaration from QP
• In case that an electronic signature is provided
  the above mentioned documents are not required in
  paper

24
BDA expectations for MPR and DCP in the future

• Further increase in the MRP and DCP volume, on
  account of pure NP
• Less paper more electronic submissions
• Position of RMS - at earliest in the first
  quarter of 2009

25
Further aims

• Increase in human capacity of BDA
• More trained human resources
• Strengthening of regulatory, scientific,
  organizational and technical capacity

26

• Thank you!