TAIWAN BFDA PROMISES TRANSPARENCY ON PHARMA

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.

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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.

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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