US embassy cable - 05TAIPEI1071

UNCLAS SECTION 01 OF 02 TAIPEI 001071 
 
SIPDIS 
 
STATE FOR EAP/RSP/TC, STATE PASS AIT/W AND USTR, USTR FOR 
KI, COMMERCE FOR 4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN 
 
E.O. 12958: N/A 
TAGS: ECON, TW 
SUBJECT: TAIWAN BFDA PROMISES TRANSPARENCY ON PHARMA 
VALIDATION 
 
1.  Summary:  Taiwan's Director of the Bureau of Food and 
Drug Analysis confirmed to AIT and a visiting Department of 
Commerce official March 9 that his bureau was fully 
responsible for the development and implementation of 
pharmaceutical validation and site inspection requirements. 
He promised transparency and improved communications between 
his agency and PhRMA on the development of risk priority 
numbers for manufacturers applying for site certification. 
BFDA raised the possibility of negotiating a Mutual 
Recognition Agreement that would exempt FDA approved U.S. 
manufacturers from potential inspection in return for similar 
treatment from FDA.  End Summary. 
 
============================================ 
BFDA Takes Charge, Clarifies RPN Eligibility 
============================================ 
 
2.  Department of Commerce, International Trade 
Administration Taiwan Desk Officer Jeffrey Dutton and members 
of AIT/T's Econ and Commercial sections met with BFDA 
Director Erick Suen and his staff to discuss the status of 
pharmaceutical validation requirements, specifically the 
development of risk priority numbers (RPNs) assigned by BFDA 
to companies applying for certification of pharmaceutical 
manufacturing sites.  Industry in the U.S. has expressed 
serious concerns about the methodology and application of 
RPNs.  In previous discussions with the Bureau of 
Pharmaceutical Affairs (BOPA), the Taiwan agency originally 
involved in validation negotiations, manufacturers were told 
they would be allowed to file abridged documentation but that 
doing so would lead to the assignment of a RPN and invariably 
an inspection by BFDA.  Those who filed complete dossiers 
would not be assigned an RPN and would therefore be exempt 
from inspection.  Manufacturers agreed that BFDA has the 
right to inspect, but protested that the proposed system was 
not risk-based.  Subsequent conflicting information from BOPA 
and BFDA suggested there was no longer unanimity on the 
practice of exempting those companies that file full dossiers 
from inspection. 
 
3.  Director Suen began by clarifying that BOPA was no longer 
responsible for pharmaceutical validation issues and that, as 
of July 2004, BFDA had assumed full and final responsibility 
for all matters pertaining to validation and overseas 
inspections.  Suen went to great pains to emphasize BFDA's 
commitment to clarity, communication, and transparency and 
promised that any changes in the review procedure arising 
from the shift would be made in that spirit.  In response to 
a question regarding the scope of RPNs, Suen reconfirmed the 
content of his letter of January 10 in which he told PhRMA 
that all manufacturers, foreign and domestic, regardless of 
documentation, would be assigned RPNs. 
 
==================== 
Taking PhRMA's Views 
==================== 
 
4.  Suen also confirmed that BFDA had received PhRMA's input 
and had adopted several of their suggestions including 
exempting those manufacturing sites that volunteer for 
inspection from the RPN process and adjustments to the 
weightings of individual factors used to calculate the RPN. 
BFDA plans to release the methodology to PhRMA in a meeting 
scheduled for March 18.  AIT urged BFDA to allow time for 
PhRMA to comment on the methodology before it is implemented. 
 Suen was reluctant to commit to do so, but offered that 
implementation would not begin until several months after the 
RPN process was announced and that the risk factors would be 
periodically revised. 
 
======================================== 
Inspection Notice and Mutual Recognition 
======================================== 
 
5.  Some manufacturers in the U.S. have reportedly raised 
concerns that requirements for site inspections by BFDA may 
not be fully clear to those being inspected in advance.  Suen 
asked us to reassure these manufacturers that all standards 
and requirements for those companies undergoing inspection, 
either voluntarily or as a result of a high RPN, will be 
announced well in advance.  Suen passed AIT a draft (in 
English) of proposed timelines and fees for both voluntary 
and RPN-based inspections that allow 120 days advance notice 
to BFDA in the case of voluntary inspection requests and 120 
days advance notice from BFDA for manufacturing sites 
selected for inspection.  BFDA estimates that the fee for 
inspections in the U.S. and EU will be approximately 
US$80000.  This draft has been faxed back to State and 
Commerce. 
 
6.  Suen noted that Taiwan's BFDA has already conducted 25 
voluntary inspections, including five in the U.S.  In a 
meeting in early 2004, BFDA announced plans to conduct 40 
inspections in 2005.  Suen acknowledged BFDA was unlikely to 
meet that target.  He agreed that U.S. companies with US FDA 
certification should be exempt from the inspection 
requirements, but insisted that doing so would require a 
mutual recognition agreement (MRA) that would also exempt 
Taiwan manufacturers from FDA inspection.  Taiwan does not 
have a MRA on pharmaceuticals with any country, although the 
U.S. and Taiwan have had a formal Exchange of Letters on 
Medical Device registration. 
PAAL