48 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m
document, in general it indicates a similar direc-
tion of travel for the UK."
The UK and MHRA are both striving to make
the country an example of excellence in public
health and patient safety on the global stage, which
should be made possible through regulation and
continuing to advance innovation, Gough notes.
To achieve this global position, MHRA has speci-
fied that opportunities to progress the regulatory
framework will be taken, ensuring that regulations
are apace with life science developments without
risking patient protection.
"Unfortunately, the UK government announced in
early August 2021 that following Brexit they would
be reducing the MHRA's staff by about 300 posi-
tions or 20% of its total workforce," Gough asserts.
"It is difficult to see how the MHRA can implement
their ambitious Delivery Plan 2021–2023 with such
a drastic reduction in staff and the industry re-
sponse to this reduction has been generally negative."
"The UK Medicines and Medical Devices Act
2021, which was finalized in February 2021, pro-
vides the UK government with the powers to
implement new regulations to deliver the changes
envisaged within the UK and, potentially, these
changes could be made sooner than the changes
in the EU," Gough explains.
For Marton, the UK and EU will remain aligned
in terms of legislation as divergence between the
regions is undesirable. "Both sets of legislation,
from the UK and EU, will evolve in parallel, incor-
porating all of the experience accumulated over the
years to ease the circulation of medicines and raw
materials between the two regions," she confirms.
"Indeed, the MHRA was the main contributor in
setting the EU legal framework for medicine, and I
can only believe that the UK agency will continue
to collaborate with EU authorities in the future—
as many other authorities are doing (such as the US
Food and Drug Administration, the Pharmaceu-
ticals and Medical Devices Agency in Japan, and
the Therapeutic Goods Administration in Aus-
tralia, etc.)—to support legislative harmonization
as much as possible, and pool experience towards
ongoing improvements."
References
1. EC, "Affordable, Accessible, and Safe Medicines for All: The Com-
mission Presents a Pharmaceutical Strategy for Europe," ec.europa.
eu, Press Release, Nov. 26, 2020.
2. EC, Directive 2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community Code Relating to
Medicinal Products for Human Use, Nov. 6, 2001.
3. EC, Regulation (EC) No 726/2004 of the European Parliament and
of the Council of 31 March 2004 Laying Down Community Proce-
dures for the Authorization and Supervision of Medicinal Products
for Human and Veterinary Use and Establishing a European Medi-
cines Agency, March 31, 2004.
4. P.H. Gough, "Summary of the European Commission's Pharma-
ceutical Strategy for the European Union," input taken from Phar-
maceutical Legislation Update Subscription Service training course,
nsf.org [accessed Sept. 8, 2021].
5. EC, "Revision of the EU General Pharmaceuticals Legislation,"
ec.europa.eu [accessed Sept. 1, 2021].
PT
Industry Perspectives
Aizon ................................................................................................................. 17
Contec ............................................................................................................... 15
Jordi Labs, LLC..................................................................................................35
MasterControl Systems .................................................................................25
Patheon ............................................................................................................21
PDA .................................................................................................................... 11
Renishaw ..........................................................................................................33
Veltek ................................................................................................................... 5
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