Reprinted from PHARMACEUTICAL ENGINEERING®
The Official Magazine of ISPE
July/August 2012, Vol. 32 No. 4
www.PharmaceuticalEngineering.org
©Copyright ISPE 2012
ISPE
ISPEUpdate
Update
ILF Engage with Asian Regulators in Japan and China
by Robert Tribe, ISPE Asia Pacific Regulatory Affairs Advisor
T
he International Leadership Forum (ILF), which usually
meets in the USA or Europe at least twice a year, held
meetings in Asia for the first time in April 2012. The
meetings were chaired by Lou Schmukler, President Global
Manufacturing and Supply, Bristol Myers Squibb Co.
The ILF met in Hiroshima, Japan on 13 April 2012 in
conjunction with the annual ISPE Japan Conference which
was the 10th Anniversary of the Japan Affiliate. It also met
in Beijing, China on 15 April 2012 in conjunction with the
annual ISPE China Conference.
Senior regulators from MHLW (Japan), PMDA (Japan),
SFDA (China), Shanghai FDA, Beijing FDA, Zhejiang FDA,
Shandong FDA, PIC/S, and MHRA (UK) attended the meetings
to discuss top industry concerns, participate in frank panel
discussions, and provide input to the finalization of the ILF
Global Positioning Strategy (GPS) document.
The GPS document was well received by the regulators and
valuable input was shared to help facilitate the finalization of
the document. The final draft of the GPS document is available for review and comment at: http://www.ispe.org/index.
php/ci_id/36256/la_id/1.htm
The main discussions concerning regulatory issues that
arose during the ILF meetings were as follows:
Japan Regulatory Issues:
• On 9 March 2012, the MHLW applied for PIC/S membership in its name as well as on behalf of the PMDA and the
Japanese Prefectures.
• There were essentially 48 GMP Inspectorates in Japan
(one central Inspectorate and 47 Prefecture Inspectorates).
• All 48 Inspectorates will work to the same single Quality
Management System in order to help ensure a uniform and
consistent approach to the inspection and authorization
of manufacturers of pharmaceutical products in Japan.
• Regular training seminars are held for the inspectors
of all 48 Inspectorates in order to help ensure uniform
interpretation of the Japan GMP requirements.
China Regulatory Issues:
• The China GMP (2010 revision) was implemented by SFDA
on 1 March 2011. It contains 14 chapters and 313 articles
as basic GMP requirements, and is similar in approach
and content to the EU and WHO GMP requirements
(http://eng.sfda.gov.cn/WS03/CL0768/65113.html). There
are currently five annexes which cover sterile products,
APIs, biologicals, blood products, and Traditional Chinese
Medicines (TCMs). Discussions will be held later in 2012
to include additional annexes to bring the content of the
China GMP closer to the EU and PIC/S GMP Guides.
• There are two levels of GMP inspections in China; at the
national level, the SFDA inspect manufacturers of higher
risk pharmaceutical products (such as sterile products and
biologicals), while at the local level, the provincial FDAs
inspect manufacturers of other pharmaceutical products
(such as non-sterile products, APIs, etc.)
• Manufacturers in China were given the following timeframes to comply with the new China GMP:
- For higher risk pharmaceutical products: up until the
end of 2013
- For other pharmaceutical products: up until the end of
2015
• A company is required to obtain the following three documents in order to sell pharmaceutical products in China:
1. A manufacturer authorization certificate
2. A product licence
3. A GMP certificate
Manufacturers must apply for a GMP inspection after
obtaining the first two documents. The manufacturer will
not be allowed to produce pharmaceuticals without GMP
certification from the regulatory authority (this will apply
after the end of the relevant transition period of either
2013 or 2015).
• The SFDA website currently has a searchable database of
medicine manufacturers that have been inspected (only in
Chinese language at this stage). This database shows for
each manufacturer the scope of the inspections conducted
by SFDA and the history of compliance with the China
GMP (2010 revision) and the previous version.
• The SFDA has commenced conducting overseas inspections
as a pilot program to gather information. So far, seven
manufacturers from five different countries had been inspected under this program with more inspections planned.
The inspections undertaken to date have revealed some
differences in China GMP requirements in comparison to
other GMP requirements.
Concludes on page 2.
July/August 2012 PHARMACEUTICAL ENGINEERING
1
ISPE Update
ILF Engage with Asian Regulators in Japan and China
Continued from page 1.
Glossary of Regulatory Authorities
attending the Asia ILF Meetings
• The SFDA had participated in PIC/S meetings and training seminars over the past few years and is interested in
applying for PIC/S membership sometime in the future.
PIC/S Regulatory Issues:
• PIC/S is a different kind of organization to that of ICH.
While PIC/S membership comprises 40 regulatory authorities from all over the world, ICH membership comprises
both regulatory and industry representatives from only
three regions of the world – North America, Europe, and
Japan. Because PIC/S is open only to regulatory authorities, it is most unlikely that PIC/S and ICH would merge,
although they will continue to cooperate with each other.
• PIC/S is an informal cooperative arrangement between
regulatory authorities and unlike an Mutual Recognition Agreement (MRA) between countries, it had no legal
status or treaty status. Because of this, it is very common
for PIC/S member authorities to exchange information
on GMP inspections without any obligation to accept the
results of inspections.
• A wide range of information is exchanged between PIC/S
member authorities, including GMP inspection reports,
forward inspection schedules (to avoid duplication of
inspections), investigation reports, rapid alerts, drug
recalls, training courses for inspections, and databases of
manufacturers that are inspected and licensed, etc.
• Once a regulatory authority becomes a member of PIC/S,
they are subjected to periodic reassessment to ensure that
their systems, procedures, and inspection standards remain
equivalent to PIC/S requirements.
• The regulatory authorities of Slovenia, USA (US FDA),
and Ukraine were the most recent authorities to become
members of PIC/S. The regulatory authorities of Japan
and South Korea were the most recent authorities to apply
for PIC/S membership with the authorities of Indonesia,
Thailand, Philippines, New Zealand, Taiwan, Brazil, Iran,
and UK (veterinary) currently being assessed for membership.
(Note: several weeks after the ILF meeting, PIC/S announced
that the regulatory authority of Indonesia will become the
41st member of PIC/S from 1 July 2012).
Schmukler thanked the regulators and all participants for
their frank and active participation in the meetings, and
indicated that it was likely that the ILF would repeat the
meetings in Asia in the future.
2
PHARMACEUTICAL ENGINEERING July/August 2012
MHLW
Ministry of Health, Labour and Welfare,
Tokyo, Japan
PMDA
Pharmaceuticals and Medical Devices
Agency, Tokyo, Japan
SFDA
State Food and Drug Administration, Beijing,
China
Shanghai FDA Food and Drug Administration of Shanghai,
China
Beijing FDA
Food and Drug Administration of Beijing,
China
Zhejiang FDA Food and Drug Administration of Zhejiang,
China
Shandong FDAFood and Drug Administration of Shandong,
China
PIC/S
Pharmaceutical Inspection Cooperation
Scheme, Geneva, Switzerland
MHRA
Medicines and Healthcare Products Regulatory Agency, London, UK
About the ILF
The ILF was formed 20 years ago. It is a global advisory
group comprised of senior leaders from the pharmaceutical industry dedicated to:
• Providing leadership and direction on critical issues
facing the pharmaceutical industry
• Aligning the pharmaceutical industry globally
• Establishing dialogue with regulators to discuss
critical technical issues
• Identifying opportunities for innovation
• Promoting consistency
• Seeking worldwide harmonization where appropriate
The ILF provides direction on focus and priorities to
guide the strategic plan and activities of ISPE, and to
coordinate interactions with other professional societies.
The ILF operate independently of ISPE although ISPE
provides administrative support.