Staffdel Knauer Discusses Drug Export Safety with China

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TAGS: TBIO PREL HHS ETRD BEXP CH
SUBJECT: Staffdel Knauer Discusses Drug Export Safety with China
Regulators


1. (SBU) Summary: In a meeting with Staffdel Knauer on September
3, officials at China's State Food and Drug Administration (SFDA)
described a rigorous inspection system for imports and exports of
active pharmaceutical ingredients (APIs),but admitted that there is
a "fatal" gap in the system between exported APIs and bulk
chemicals. SFDA employs 1500 inspectors countrywide who conduct
inspections of domestic Chinese drug manufacturers at least once
each year. While welcoming more cooperation with the U.S. FDA, SFDA
expressed some concerns about a permanent FDA presence in China. In
a subsequent meeting with the General Administration of Quality
Supervision, Inspection and Quarantine (AQSIQ),Vice Minister Wei
Chuanzhong assured the Staffdel that AQSIQ has developed a good
working relationship with counterpart agencies in the United States
and will be leading a delegation to Washington on September 9 for
consultations on food safety issues. He also pointed out that API
exports are all handled by SFDA; AQSIQ only deals with shipments
that are identified by importers as bulk chemicals. End summary.



2. (SBU) In a meeting at SFDA on September 4, Christopher Knauer,
Peter Spencer and Paul Jung of the House Energy and Commerce
Committee, met at SFDA with Director General for International
Cooperation Xu Youjun and Deputy Director General of Drug
Registration Yang Wei. Xu and Yang reported that they were involved
in the discussions with U.S. Health and Human Services (HHS) on an
MOU that will cover drug quality and safety. They confirmed that
the Chinese side had agreed on the date of September 17 next visit
to China by the HHS delegation that is negotiating the MOU. Xu
pointed to these discussions as an indication of a new level of
cooperation between the two agencies.

FDI Presence in China "Difficult"
--------------


3. (SBU) Mr. Knauer commented on the increasing globalization of
drug manufacturing and how difficult it has become for FDA to
inspect all of the overseas plants that export to the United States.
He wondered if having a permanent FDA presence in China would help
address this problem. In response, DG Xu suggested that a permanent
FDA presence in China would be "difficult" and "may not be very
practical." She said China is committed to improving its own
inspection system and noted that China has established a working
group on product safety that involves seven ministries and has
launched a new rectification campaign that aims to strengthen
relevant laws and regulations. She suggested that that the Good
Manufacturing Practices (GMP) certification should be a global
standard and that SFDA, which currently has 1500 inspectors, has
already certified 4,682 firms in China.


4. (SBU) DDG Yang argued that both SFDA and FDA share the same
vision of ensuring safety and identified the API issue as an area
deserving special attention in the bilateral discussions. Yang
noted that as of 2004, all APIs require SFDA certification.
Inspections of API manufacturers are conducted on a yearly basis,
with at least 25 percent of the inspections being unannounced.
Imported APIs must be inspected at the port and every lot must be
inspected separately. Yang confirmed that SFDA also conducts
post-surveillance and post-approval inspections. While most
inspections are done by provincial SFDA inspectors, all inspections
of "high risk" materials are organized by the central government's
SFDA. The four categories of "high risk" drug products are: 1)
biological products (e.g., blood, vaccines),2) large volume
injectables, 3) traditional Chinese medicine injectables, and 4)
recombinant biochemical products.

APIs a "Fatal" Gap
--------------


5. (SBU) Yang reported that for APIs, SFDA tests every batch. He
noted that the United States does not currently have such a system
and urged the FDA to strengthen its inspection of API imports. In
this effort, China is willing to provide a list of registered API
exporters. He pointed out that the critical "fatal" gap in the
current arrangement is that some API exports to the United States
are labeled as bulk chemicals. As such, they can therefore elude
SFDA oversight.

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6. (SBU) In a follow-on meeting with AQSIQ, Vice Minister Wei
Chuanzhong told the Staffdel that he had previously met with
Staffdel Nelson and Representatives Kirk and Larson (see septels).
Reviewing points shared with the previous visitors, VM Wei noted
that he will be leading a delegation to the United States on
September 9 that will focus on establishing a cooperative framework
with FDA, HHS, the U.S. Department of Agriculture and the Consumer
Product Safety Commission. He reported that according to his
agency's figures, Chinese exports to the United States from 2004 to
2006 had consistently scored above 99 percent in terms of quality.
He complained that any problems were simply isolated incidents and
that the media had distorted the true picture. Wei maintained that
AQSIQ, especially at the local level, has developed a strong working
relationship with FDA.



7. (SBU) Mr. Spencer asked Wei how AQSIQ and SFDA work together on
APIs exports. Wei said SFDA handles all matters related to
pharmaceutical products, including APIs. AQSIQ has no role with
regard to bulk pharmaceuticals; only bulk chemicals products need
AQSIQ approval. Wei confirmed that there is no way to tell the
difference - it is the importer who states what the chemical will be
used for and it can thereby be classified as an industrial, food or
pharmaceutical product.


8. (U) This report was cleared by the delegation.

RANDT