Fine Chemicals
Will Ireland remain the number one place
for validating and launching NDAs? Nowhere
else comes close in terms of compliance
with GMPs and HSE. And will other places
in Europe be producing intermediates for
the f_i rst generation process? Will India and
China be limited to providing the building
blocks for the second generation process? As
for the generics sector, the answer is simple:
the generic drug is already a mostly Asian
product, and only effective enforcement
of regulations can stop a worrying trend
towards a level of risk that is becoming
unacceptable. Absent the imposition of
quality standards by a regulator through
deterrence and effective inspections of
being discussed in Washington right now pharma’s globalisation. The correct options
primary and secondary manufacturing (and
contemplates mandatory disclosure are not the most obvious – yet it is clear that
across the distribution chain) competition will
of the country of origin of the API in the deliberate and decisive actions are urgently
make sure the purchasing department will
drug product packaging. The EDQM has required to meet challenges and discharge
win every time over the quality unit.
recently altered its policy,
12
and its DMF responsibilities.
patient safety
database will disclose for each API all the
References
sites used, not just the one involved in the
For the regulators, 2008 was a turning point,
f_i nal step. Is it not time for the EU to have a 1. The Changing dynamics of pharma
even before the heparin disaster broke out.
foreign inspection service? outsourcing in Asia: Are you readjusting your
On both sides of the Atlantic, politicians
sights?, PricewaterhouseCoopers,
and lawmakers had started to point out
that the regulatory infrastructures, insofar as There is still no system in place
www.pwc.com/pharma
supervision of generics was concerned, were
2.
www.gsk.com/media/
to ensure that EU customs
woefully obsolete and unable to maintain
pressreleases/2008/2008_
effective oversight over this globalised
block the entry of APIs coming pressrelease_10086.htm
industry. Built to keep an eye on a national
from producers known to be
3.
www.marketwatch.com/news/story/
industry, Europe’s medicines agencies today
stare impotently over billions of parallel
non-compliant
astrazeneca-ceo-says-firm-mulls/story.
aspx?guid=%7B922F9FAD-A243-4379-
imports within the EU and over a f_l ood of A019-3B75FF78E159%7D
APIs pouring into Europe after DMFs are
approved on a “paper-only” review. When
Another statistic likely to raise some
4.
www.reuters.com/article/pressRelease/
inspections to plants identify non-compliant
question marks relates to how, whenever
idUS36338+01-Jan-2008+PRN20080101
situations, a “rapid alert” is raised and we
there is a major quality issue with an API
5.
http://business.timesonline.co.uk/tol/
have seen recalls, but there is still no system
(which is global, by the very nature of
business/industry_sectors/health/
in place to ensure that EU customs block the
the supply chain), it only seems to affect
article2468741.ece
entry of APIs coming from producers known
Americans – Europeans appear to be immune
6.
www.britest.co.uk
to be non-compliant.
to such events. If we look at the disasters
7.
http://www.fda.gov/ohrms/dockets/ac/06/
After around 150 inspections worldwide
caused by sub-standard APIs (for instance,
slides/2006-4241s1_6.ppt; http://www.
(>65% in Asia, most others in Europe)
L-tryptophan, gentamycin sulfate and heparin/
emea.europa.eu/Inspections/PAThome.html
conducted over a period of under 10 years,
oversulphated chondroitin sulphate (OSCS))
8.
http://www.idaireland.com/home/index.
the European Directorate for the Quality of
deaths were only reported in the US. What
aspx?id=3
Medicines & Healthcare (EDQM) has in total
are we supposed to conclude? That Europe
suspended or withdrawn almost 40 CEPs
has safer generics? That European data
9.
http://www.edb.gov.sg/edb/sg/en_uk/index.
(Certif_i cate of Suitability). This means that
gathering has f_l aws? Or is it something else?
html
large quantities of 40 very unsafe APIs have
At present, and for the foreseeable 10.
http://www.pwc.com/
for years been administered to patients in
future, large pharma will remain the major
11.
http://ec.europa.eu/enterprise/
the EU.
driver, and valuable contributor, to the
pharmaceuticals/counterf_par_trade/
From a patient safety perspective those
pharmaceutical standard-setting process.
conterfeit_doc/2008_04_presentation-
CEPs should never have been granted in
The consultation process over regulations,
counterfeit.pdf
the f_i rst place. All the CEP suspensions and
guidelines, monographs, ICH standards, etc,
12.
www.edqm.eu/medias/fichiers/NEW_Policy_
withdrawals by the EDQM related to API
has limited generic involvement. However, the
on_stating_manufacturing_sites_on_CEPs.
manufacture in Asia, compared with zero in
big pharma industry is no longer the major
pdf
Europe. But the EFCG has always applauded
player: generics now f_i ll more than half of
the EDQM because until recently it was the
all prescriptions worldwide. Is this not likely
only European entity that arranged for API
to lead to an increasing disconnect between
inspections outside of Europe.
standards and the fastest growing part of the
Guy Villax is the CEO of
In April 2008, we saw for the f_i rst
pharma reality? Could this disconnect cause
Hovione and a board member
time the European Commission aiming for
the credibility of our drug system to erode?
of EFCG.
“mandatory inspections in third countries
Companies and regulators are short of
without equivalent GMP and inspection much needed expertise to understand the
standards”.
11
Over in the US, one of the bills new shape and forces that are accelerating
www.scripnews.com/supplements Scrip 100
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