Cablegate: Phrma and Taiwan Agree On Computer Validation

This record is a partial extract of the original cable. The full text of the original cable is not available.

052248Z Oct 05

UNCLAS SECTION 01 OF 02 TAIPEI 004094

SIPDIS

STATE FOR EAP/RSP/TC AND EB/TPP/BTA, STATE PASS AIT/W AND
USTR, USTR FOR WINELAND AND WINTERS, USDOC FOR
4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN AND JDUTTON

E.O. 12958: N/A
TAGS: ECON ETRD TW
SUBJECT: PHRMA AND TAIWAN AGREE ON COMPUTER VALIDATION

REF: A. TAIPEI 3807

B. TAIPEI 2078

1. Summary: AIT and the Pharmaceutical Research
Manufacturers Association (PhRMA), accompanied by
representatives of Japanese and European pharmaceutical
associations, met with Taiwan's Bureau of Food and Drug
Analysis (BFDA) to discuss pharmaceutical validation
requirements. The positive tone set by the new director
general of the BFDA and the presence of other international
pharmaceutical associations resulted in fruitful discussions
that essentially resolved questions of computer validation
requirements and led to progress on finalizing the
methodology for determining which manufacturing sites will be
the first to be inspected. End summary.

2. On September 13, AIT accompanied members of PhRMA, the
Japanese Pharmaceutical Manufacturers Association (JPMA) and
the European Federation of Pharmaceutical Industries and
Associations (EFPIA) to meetings with BFDA, and Bureau of
Pharmaceutical Affairs (BOPA)(reported reftel a.) In sharp
contrast to PhRMA's April meeting on pharmaceutical
validation with BFDA (reftel b), discussions this time were
calm and productive. Both sides were well prepared and the
reasonableness of the new BFDA Director General Chen Shu-kong
was a welcome relief. Discussions focused on implementation
of computer validation requirements (information on a
pharmaceutical manufacturers computerized systems, training,
and software and hardware management protocols) for
manufacturing sites and clarifications on BFDA's method of
calculating the Risk Priority Number (RPN) used to determine
BFDA's inspection schedule.

============================================
Japan and EU Weigh In on Computer Validation
============================================

3. In response to Dr. Chen's initial question about
requirements for computer validation by health authorities in
other countries, JPMA representative Kenta Goto explained
that in order to guarentee product quality, Japan has had a
mandatory computer validation requirement in place for many
years. Although Japan's laws and regulations covering
computer validation have been subject to revision, the actual
requirement has effectively been in place continuously since
1993. Malcolm Holmes, from EFPIA, informed Chen that an EU
Directive required that all EU members must have a law
requiring computer validation regimes in place in their
national codes by April 2004. After that date, if no law
existed, the EU regulation requiring the same would take
precedence. Newly acceding EU states must be in compliance
upon accession. Holmes added that several EU regulations and
directives have addressed the issue of computer validation
requirements since 1991.

4. BFDA agreed to accept government issued Certificates of
Pharmaceutical Product from the US, Japan and the EU as
effectively complying with the Taiwan requirement for
computer validation, but requested more information from both
the EU and Japan about their current regulations. Moreover,
BFDA requested that manufacturing sites provide computer
manuals and standard operating procedures or reference
numbers of manuals for BFDA to review.

5. Guy Wingate, also from EFPIA and an expert on computer
validation, responded that BFDA's over-reliance on documents
as a means to prove the existence of good computer system
practices was impractical. Wingate noted that most factories
would have thousands of computerized systems operating
simultaneously and with constantly changing procedures,
providing manuals or reference numbers to BFDA for each of
them would not only be an onerous requirement, it would be of
questionable value. Instead, he suggested that a paragraph
describing the structural testing regime and computer system
lifecycle be included in the overview of manufacturing
practices submitted by each company to BFDA. After some
discussion and internal debate, BFDA agreed to consider
EFPIA's proposal.

=============================
Who Will Get Inspected First?
=============================

6. Finally, the discussion turned to the methodology used by
BFDA to compute the RPN. International pharmaceutical
manufacturers disagree with the need for BFDA to conduct
regular inspections of international pharmaceutical
manufacturers, believe BFDA is more interested in creating a
cadre of experienced inspectors through unnecessary
inspections and are concerned that the weighting of several
of the criteria, including extra emphasis on previous records
of recalled products, was unbalanced. BFDA agreed to
distinguish between voluntary and mandatory recalls in the
determination of the RPN and to give a higher score to those
areas with weak regulatory oversight. BFDA also agreed to
keep confidential the RPN of each manufacturing site.

7. Comment: The patience and reasonableness of the new
Director General of BFDA, as well as the sound preparation by
experts from JPMA and EFPIA, were crucial to the success of
this series of meetings. PhRMA and the other international
pharmaceutical associations are not pleased by the prospect
of their manufacturing operations being inspected by BFDA.
They view this as a time-consuming and expensive endeavor,
with limited value in the majority of cases. However, they
appear to be resigned to this new requirement and can take
heart from the fact the BFDA does not have the capacity to
inspect more than a handful of sites each year -- their goal
of 50 inspections in 2005 is likely to be closer to 20. The
outline of the agreement on computer validation requirements
appears to be a win for the industry, but as always, the
proof will be in the shape of the published requirements, a
copy of which BFDA promised to provide soon. End Comment.
PAAL

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