Sexual HealthTransatlantic Regulatory Integration Of Drug Approval Process Vital For The Global Pharmaceutical Industry, Notes Frost & Sullivan
Regulatory processes differ across continents,
posing challenges to drug launches. There is a pressing need to integrate
the regulatory environment of the European Union (EU) and the U.S. Diverse
regulations impact drug launches as less price controlled markets witness
quicker launches, while it takes longer in regulated markets. The
pharmaceutical industry, along with regulatory agencies, has been working
closely with the The International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH) to develop a standard set of regulatory processes for Europe, the
U.S., and Japan.
New analysis from Frost & Sullivan , Drug
Approval Process in Europe - An Outlook, provides an insight into the
mutual recognition procedure, centralised procedure, price controls, and
parallel trading. In this research, Frost & Sullivan"s expert analysts
thoroughly examine the EU regulatory processes, comparing the EU and the
U.S. drug approval processes, price controls and parallel trading,
biosimilars approval, and bi-lateral and tri-lateral integration.
"The future of the pharmaceutical industry lies in the globalisation of
the drug approval processes" notes Frost & Sullivan Programme Leader
Sylvia Miriyam Findlay. "Pan-European integration and transatlantic
coordination on the regulatory front is high on the agenda for Europe,
Middle East and Africa (EMEA) and the Food & Drug Administration (FDA) in
the Unites States."
Several companies are venturing into manufacturing biosimilars, since
biologics are on the verge of patent expiry. This has led to the formation
of new regulatory pathways for biosimilar approvals in the EU. The EU has
pioneered the creation of a regulatory pathway for biosimilars in Europe.
However, the gap between European regulatory authorities and national
pricing authorities needs to be bridged. Although centralised procedures
authorise the sale of drugs in all member states, pharmaceutical companies
still have to file for price or reimbursement approvals. Some countries
have distinct methods of drug price approvals and their processes are not
always transparent, making it difficult for drug manufacturers to do
business in Europe.
"The unfavourable regulatory environment, varying price controls across
member states, and parallel trading hinder the growth of the
pharmaceutical industry in Europe," explains Findlay. "Due to the varied
price regulations across EU, research intensive firms undertake R&D
activities in less price controlled markets."
EU wide synchronisation will make the approval process faster, reducing
delays in drug launches. Transatlantic co-ordination will also aid in
streamlining regulatory costs. Transatlantic regulatory convergence will
have immense benefits such as faster technology transfer, regulating
approval of unsafe drugs, and patent law harmonisation.
"EMEA should encourage frequent dialogues with patient and industry
representatives to ensure a transparent approval process," notes Findlay.
"Such interaction will also aid in redefining the clinical trial design
and streamline the drug approval process."
Drug Approval Process in Europe - An Outlook is part of the
Pharmaceuticals & Biotechnology Growth Partnership Service programme,
which also includes research in the following markets: European Vaccines
Market, European Biosimilars Market, and European Orphan Diseases Market.
All research services included in subscriptions provide detailed market
opportunities and industry trends that have been evaluated following
extensive interviews with market participants. Interviews with the press
are available.
GIL 2009: Europe
Frost & Sullivan has expanded its flagship Global Congress on Corporate
Growth - GIL Global - into several major cities around the world including
London. For the first time ever in Europe, Frost & Sullivan will be
hosting the Growth, Innovation and Leadership Congress "GIL 2009: Europe"
today and tomorrow, 19-20 May, at the Sofitel St James in London. GIL
Global is the industry"s only event designed to support senior executives
in their efforts to achieve sustainable, top-line growth. To register,
obtain a programme agenda, explore sponsorship opportunities, or attend as
a member of the media for GIL 2009: Europe, please contact Katja Feick,
Corporate Communications Europe, at katja.feick@frost.com. One-on-One
interviews with Frost & Sullivan senior growth consultants are also being
scheduled. For more information you can also visit
http://www.frost.com/gilglobal
Frost & Sullivan