US embassy cable - 05TAIPEI2078

C O N F I D E N T I A L SECTION 01 OF 02 TAIPEI 002078 
 
SIPDIS 
 
STATE FOR EAP/RSP/TC, STATE PASS AIT/W AND USTR FOR KI AND 
FREEMAN, USDOC FOR 4431/ITA/MAC/AP/OPB/TAIWAN/MBMORGAN AND 
JDUTTON 
 
E.O. 12958: DECL: 05/05/2015 
TAGS: ECON, ETRD, TW 
SUBJECT: PHARMACEUTICAL VALIDATION: A METHOD? OR MORE 
MADNESS? 
 
 
Classified By: AIT Director Douglas Paal, Reason 1.4 (b) 
 
1.  (U) Summary: Representatives from PhRMA accompanied AIT 
to meetings with Taiwan Department of Health (DOH) officials 
to discuss pharmaceutical validation issues on April 28.  AIT 
intervention salvaged a heated exchange between PhRMA, 
Taiwan,s Bureau of Food and Drug Analysis (BFDA) and local 
pharmaceutical association representatives.  BFDA's Risk 
Profile Number (RPN) methodology continues to lack 
transparency but the meeting eventually led to promises of 
useful clarifications of terms.  A brief discussion of BFDA 
proposed computer validation requirements reassured PhRMA 
that Taiwan's requirements should not be too difficult to 
meet.  In a separate meeting, Taiwan,s Bureau of 
Pharmaceutical Affairs (BOPA) agreed to allow PhRMA to 
provide input into the draft guidelines for review of Active 
Pharmaceutical Ingredients (API) and agreed to extend import 
licenses for medical devices in the registration process 
until the end of 2005.  End Summary. 
 
2.  (U) In response to a request by the Pharmaceutical 
Research Manufacturers Association (PhRMA) and the 
International Research Pharmaceutical Manufacturers 
Association (IRPMA), Acting Director General of Taiwan,s 
BFDA, Erick Suen called a meeting of pharmaceutical 
manufacturers to discuss outstanding validation issues 
including the methodology for assigning RPNs and requirements 
for computer validation.  Cynthia Wang (Merck), Allan Chu 
(Eli Lilly), Roy von Kutzleben (Pfizer), and Marie Vodicka 
(PhRMA), joined IRPMA's Executive Director Carol Cheng and 
AIT Econ and Commercial officers in attending. 
 
-------------------------------- 
BFDA Wants an RPN Resolution Now 
-------------------------------- 
 
3.  (SBU) Acting DG Suen was eager to reach consensus on 
acceptable RPN methodology, used to identify pharmaceutical 
manufacturing sites for inspection by Taiwan authorities. 
PhRMA was not prepared to agree to any particular 
formulations but raised several questions about the apparent 
arbitrariness of the scoring and weighting of each factor in 
the formula.  BFDA attempted to negotiate the scoring of each 
factor and was extremely frustrated by PhRMA's reluctance to 
bargain.  After a brief break that allowed participants to 
disengage and consult among themselves, Suen returned and 
agreed to hear PhRMA's concerns without insisting on 
negotiating compromises in the meeting. 
 
4.  (U) BFDA's RPN formula considers four categories: quality 
control issues, dosage forms, a Good Manufacturing Process 
(GMP) Standard and Regulatory Environment, and the volume of 
product distributed in Taiwan.  These scores are weighted and 
totaled and then used to prioritize manufacturing site 
inspections.  PhRMA expressed no concerns about scoring or 
weighting in the dosage form or volume categories, but had 
concerns about the definitions and weighting in the quality 
control and regulatory environment categories. 
 
--------------------------------------------- -- 
PhRMA Asks for Clarifications on RPN Categories 
--------------------------------------------- -- 
 
5.  (U) Specifically, PhRMA asked for clarification about the 
criteria for determining the pharmacovigilance score (based 
on BFDA's post-marketing surveillance and distributor 
complaints) and a vaguely worded catchall category for 
"special situations."  PhRMA also requested clarifications on 
scoring for those companies that had products recalled.  BFDA 
responded that the score could be differentiated based on 
whether the recall was government mandated or self-initiated 
and whether the recall was for quality or safety issues. 
 
6.  (U) PhRMA also disagreed with the scoring based on the 
regulatory environment of the manufacturing country and 
differential based on the type of documentation provided 
(full documents vs. the Certificate of Pharmaceutical Product 
(CPP) and template), arguing that these factors were 
inappropriately scored and violated BFDA's commitment to 
ensure that the RPN factors would be risk based.  BFDA 
countered that a manufacturer's willingness to submit full 
documentation was a show of compliance with Taiwan 
regulations and should be rewarded, an argument that was 
quickly rejected by AIT and PhRMA.  BFDA agreed to provide 
more detailed explanations of each factor and post them on 
the BFDA website. 
 
7.  (U) Finally, AIT and PhRMA raised questions about the 
weighting for each category.  Due to simple mathematical 
errors, it appears BFDA's formula unintentionally over 
weights the first category.  BFDA confirmed its intention is 
to weight each category as a fixed percentage of the final 
score and promised to review the math. 
 
----------------------------- 
Computer Validation Too Easy? 
----------------------------- 
 
8.  (U) Discussion of computer validation (stage three) 
procedures focused on BFDA's creation of a detailed draft 
checklist.  PhRMA expressed concern that the checklist it had 
seen was too detailed and suggested that it would be 
impossible for manufacturers to complete.  AIT urged BFDA to 
remain consistent with the principles of stage one and two 
validation and minimize additional required documentation. 
BFDA clarified that the checklists were being drafted as an 
internal tool only and that manufacturers would not be 
required to submit these documents.  Suen and his staff 
agreed that a description and overview of computer systems 
already validated by a competent national authority should 
meet Taiwan's requirement.  BFDA also requested that PhRMA 
prepare a concrete proposal for computer validation 
requirements and confirmed that it would be willing to accept 
any CPP that includes a GMP certificate issued after computer 
certification had been included in the GMP process as 
fulfillment of this requirement.  BFDA also reminded PhRMA 
that manufacturers that volunteer for inspection are exempt 
from these requirements. 
 
------------------- 
BOPA Raises GMP-API 
------------------- 
 
9.  (U) Separately, the PhRMA delegation paid a courtesy call 
on Counselor to the Minister of Health, Dr. Hsiao Mei-ling, 
and BOPA Director General Dr. Wang Hui-po.  Hsiao and Wang 
again confirmed that BFDA is the competent Taiwan authority 
for all matters related to pharmaceutical validation.  They 
also raised the issue of BOPA's review of active 
pharmaceutical ingredients (API), explaining that API reviews 
are conducted by a BOPA-assigned committee.  PhRMA noted that 
it may not be possible for all manufacturers to provide 
requested GMP-API documents since each country has differing 
requirements.  BOPA agreed to consider any input from PhRMA 
as the guidelines are being drafted. 
 
----------------------------------------- 
Good News on Registrating Medical Devices 
----------------------------------------- 
 
10.  (U) AIT Econoff took the opportunity to raise a separate 
issue regarding registration of medical devices. 
Manufacturers and importers are being required to register 
all classes of medical products by June 20, 2005 or face 
import restrictions.  Manufacturers and importers have 
expressed concern that BOPA staff will be unable to process 
registration applications by the deadline, potentially 
barring life-saving devices from Taiwan.  BOPA DG Wang said 
BOPA recognized the problem and had decided that as long as 
manufacturers submitted registration applications by the June 
20 deadline, they would not face import restrictions through 
the end of 2005. 
 
----------------------------- 
Comment: PhRMA Hurting Itself 
----------------------------- 
 
11.  (C) Comment: PhRMA's frustrating meeting with BFDA was 
in significant part a result of PhRMA's lack of coordination 
either with BFDA or AIT.  PhRMA informed AIT less than a week 
before the delegation was scheduled to arrive and made no 
effort to involve AIT in scheduling of meetings or setting of 
agendas.  The parties had widely divergent expectations for 
the meeting and it was only the timely intervention of AIT 
officials that allowed the parties to return to the table for 
what ended up being moderately productive discussions.  The 
most significant obstacle to progress in resolving 
pharmaceutical validation issues has been a lack of reliable 
communication between Taiwan,s DOH and PhRMA, all too often 
the origin of the problem has been disorganization and an 
inability or unwillingness to coordinate on PhRMA's part. 
The remaining technical issues involved with RPN calculation 
may require some compromise but should not be too difficult 
to resolve.  To do so, however, will require vastly improved 
coordination and communication between PhRMA, AIT and BFDA. 
AIT made this point clearly to PhRMA delegates and it 
appeared to be understood before they departed. 
PAAL