h********0
发帖数: 944 | 1 Following the reform of the drug and device approval system by China’s
State Council in August,1 the China Food and Drug Administration (“CFDA”)
has finally unveiled its implementation policies regarding improvements to
the drug approval system, with the November 11, 2015 release of the Circular
Concerning Several Policies on Drug Registration Review and Approval (CFDA
Circular [2015] No. 230, the “No. 230 Circular”) and several draft
implementation measures. These documents set the stage for the
transformation of China’s drug approval system and include the following
changes:
Piloting the Marketing Authorization Holder (“MAH”) system
The current legal framework only permits drug manufacturers to obtain
regulatory approvals and was perceived as an obstacle to innovation. R&D-
based companies must commit to a substantial investment in manufacturing
facilities in order to commercialize their assets. To create a more
supportive regulatory framework for innovation, the Standing Committee of
the National People’s Congress authorized the State Council to roll out a
three-year pilot program of the MAH system in 10 provinces,2 effective as of
December 1, 2015. Under the CFDA’s proposed MAH pilot program, domestic
drug manufacturers, domestic R&D institutions and research personnel of
Chinese nationality can obtain regulatory approvals to commercialize
pharmaceuticals in principle,3 and completely outsource the actual
manufacture to contract manufacturing organizations. Nevertheless, the MAH
applicants must arrange for insurance or financial guarantee to cover
product liabilities.
Expanding the fast track approval pathway
To date, the fast track approval pathway has been mainly available for drugs
that have not been marketed anywhere in the world, or those addressing
critical or unmet medical needs. The State Council has directed the CFDA to
admit more types of drugs to the fast track approval pathway, including
pediatric/geriatric drugs, drugs treating China-prevalent diseases, drugs
sponsored by national science and technology grants, foreign innovative
drugs to be manufactured locally in China, innovative drugs using advanced
technology, using innovative treatment methods, or having distinctive
clinical benefits, drugs manufactured at a US/EU qualified facility and
under review by the USFDA/EMEA for concurrent marketing authorizations. The
clinical trial applications and marketing authorizations for drugs
addressing urgent clinical needs will also be accelerated. Under this
condition, clinical trial applications submitted three years prior to the
date of patent expiration or marketing authorization applications submitted
one year prior to the date of patent expiration, will be permitted.
Changing the classifications for new drugs and generics
According to the State Council’s directive, new drugs refer to those
pharmaceutical products that have never been marketed anywhere in the world,
or those that represent improved forms of the new drugs. Generics refer to
those pharmaceutical products that are consistent with the reference drugs (
or originator drugs) quality and efficacy. These definitions are very
different from the current definitions under the CFDA’s Drug Registration
Rules. The CFDA plans to introduce a new classification system that adopts
the State Council’s definitions and will classify pharmaceutical products
that have been marketed outside China but not in China as generics.
Simplifying the approval process for clinical trials
The CFDA will adopt a one-time umbrella approval procedure, rather than a
phase-by-phase approval, for any new drugs’ clinical trial application.
Furthermore, beginning December 1, 2015, the bioequivalent study of generic
drugs will only need to undergo a recordation filing with the CFDA. In the
CFDA proposed regulatory framework for the recordation filing, the applicant
must obtain an EC approval and sign a clinical study agreement with the
clinical site prior to filing the bioequivalent study. The CFDA will
designate an information platform to record the bioequivalent study. This
platform will generate a filing number once the applicant has submitted the
required materials; the applicant can launch the bioequivalent study only
after obtaining the filing number. If there is any change to the originally
recorded bioequivalent study, the applicant must suspend the original study,
enter the changes in the online recordation platform to obtain a new filing
number, and only re-launch the study thereafter.
These initiatives illustrate the Chinese government’s clear determination
to stimulate innovation and reduce time to market for new drugs.
Pharmaceutical companies should adapt their business model to the new
regulatory landscape, for example, by exploring early-phase concurrent drug
development opportunities for innovative drugs in and outside China,
refining the product portfolio to reflect disease demographics and public
health priorities in China, revisiting the marketing authorization holder
designation for innovative drugs, and leveraging regulatory flexibilities to
acquire or spin off assets. Furthermore, foreign pharmaceutical
manufacturers should look into the feasibility of localizing the research,
development and/or manufacturing of their innovative assets in China, as the
degree of localization may also affect time-to-market under the new drug
approval system. | z****d
发帖数: 6 | 2 Have a question about the sentence
"will classify pharmaceutical products
that have been marketed outside China but not in China as generics"
Does it mean ANY foreign drug can enter the Chinese market based only on
bioequivalence studies? How about the drugs approved in countries/regions
other than the US, EU or Japan?
Does anyone have the original government doc? | h********0
发帖数: 944 | 3 Following the reform of the drug and device approval system by China’s
State Council in August,1 the China Food and Drug Administration (“CFDA”)
has finally unveiled its implementation policies regarding improvements to
the drug approval system, with the November 11, 2015 release of the Circular
Concerning Several Policies on Drug Registration Review and Approval (CFDA
Circular [2015] No. 230, the “No. 230 Circular”) and several draft
implementation measures. These documents set the stage for the
transformation of China’s drug approval system and include the following
changes:
Piloting the Marketing Authorization Holder (“MAH”) system
The current legal framework only permits drug manufacturers to obtain
regulatory approvals and was perceived as an obstacle to innovation. R&D-
based companies must commit to a substantial investment in manufacturing
facilities in order to commercialize their assets. To create a more
supportive regulatory framework for innovation, the Standing Committee of
the National People’s Congress authorized the State Council to roll out a
three-year pilot program of the MAH system in 10 provinces,2 effective as of
December 1, 2015. Under the CFDA’s proposed MAH pilot program, domestic
drug manufacturers, domestic R&D institutions and research personnel of
Chinese nationality can obtain regulatory approvals to commercialize
pharmaceuticals in principle,3 and completely outsource the actual
manufacture to contract manufacturing organizations. Nevertheless, the MAH
applicants must arrange for insurance or financial guarantee to cover
product liabilities.
Expanding the fast track approval pathway
To date, the fast track approval pathway has been mainly available for drugs
that have not been marketed anywhere in the world, or those addressing
critical or unmet medical needs. The State Council has directed the CFDA to
admit more types of drugs to the fast track approval pathway, including
pediatric/geriatric drugs, drugs treating China-prevalent diseases, drugs
sponsored by national science and technology grants, foreign innovative
drugs to be manufactured locally in China, innovative drugs using advanced
technology, using innovative treatment methods, or having distinctive
clinical benefits, drugs manufactured at a US/EU qualified facility and
under review by the USFDA/EMEA for concurrent marketing authorizations. The
clinical trial applications and marketing authorizations for drugs
addressing urgent clinical needs will also be accelerated. Under this
condition, clinical trial applications submitted three years prior to the
date of patent expiration or marketing authorization applications submitted
one year prior to the date of patent expiration, will be permitted.
Changing the classifications for new drugs and generics
According to the State Council’s directive, new drugs refer to those
pharmaceutical products that have never been marketed anywhere in the world,
or those that represent improved forms of the new drugs. Generics refer to
those pharmaceutical products that are consistent with the reference drugs (
or originator drugs) quality and efficacy. These definitions are very
different from the current definitions under the CFDA’s Drug Registration
Rules. The CFDA plans to introduce a new classification system that adopts
the State Council’s definitions and will classify pharmaceutical products
that have been marketed outside China but not in China as generics.
Simplifying the approval process for clinical trials
The CFDA will adopt a one-time umbrella approval procedure, rather than a
phase-by-phase approval, for any new drugs’ clinical trial application.
Furthermore, beginning December 1, 2015, the bioequivalent study of generic
drugs will only need to undergo a recordation filing with the CFDA. In the
CFDA proposed regulatory framework for the recordation filing, the applicant
must obtain an EC approval and sign a clinical study agreement with the
clinical site prior to filing the bioequivalent study. The CFDA will
designate an information platform to record the bioequivalent study. This
platform will generate a filing number once the applicant has submitted the
required materials; the applicant can launch the bioequivalent study only
after obtaining the filing number. If there is any change to the originally
recorded bioequivalent study, the applicant must suspend the original study,
enter the changes in the online recordation platform to obtain a new filing
number, and only re-launch the study thereafter.
These initiatives illustrate the Chinese government’s clear determination
to stimulate innovation and reduce time to market for new drugs.
Pharmaceutical companies should adapt their business model to the new
regulatory landscape, for example, by exploring early-phase concurrent drug
development opportunities for innovative drugs in and outside China,
refining the product portfolio to reflect disease demographics and public
health priorities in China, revisiting the marketing authorization holder
designation for innovative drugs, and leveraging regulatory flexibilities to
acquire or spin off assets. Furthermore, foreign pharmaceutical
manufacturers should look into the feasibility of localizing the research,
development and/or manufacturing of their innovative assets in China, as the
degree of localization may also affect time-to-market under the new drug
approval system. | z****d
发帖数: 6 | 4 Have a question about the sentence
"will classify pharmaceutical products
that have been marketed outside China but not in China as generics"
Does it mean ANY foreign drug can enter the Chinese market based only on
bioequivalence studies? How about the drugs approved in countries/regions
other than the US, EU or Japan?
Does anyone have the original government doc? | c*********t
发帖数: 78 | |
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