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