The China Food and Drug Administration ("CFDA")
recently announced several draft rules, most notably, the Draft
Amendment of the Provisions for Drug Registration (also known as
the Drug Registration Rules, DRR) and the Draft Administrative
Regulations on the Review and Approval of Drug Contract
Manufacturing ("Draft Contract Manufacturing Rules), which
will significant impact the pharmaceutical industry. The CFDA is
soliciting public comments on both Rules through early December,
1. Highlights of the Draft Amendment of the DRR
IND Approval (also known as Clinical Trial
Authorization) will be transferrable. IND Approval can be
transferred from one entity to another throughout all phases of
clinical studies concerning new drugs. An IND holder is also
allowed to change the manufacturing process, product specification,
and manufacturing location of the study drugs by filing a
supplementary application to the CFDA before entering into Phase 3
of the study.
Generic applications can be submitted and reviewed at
anytime during the patent term of the pioneer drug.
Provided that the generic manufacturer submits a non-infringing
statement on patents relevant to the drug under review, the CFDA
will not act as a gatekeeper to suspend the regulatory approval
process if the manufacturer of the pioneer drug argues for a patent
infringement by the generic manufacturer.
Administrative exclusivity for new drugs during the
monitoring period will be restricted. Under the current
DRR, the first to market manufacturer of locally produced new drugs
will have a period of up to 5 years of administrative exclusivity
(also known as the new drug monitoring period). Submissions made by
other manufacturers concerning the same active pharmaceutical
ingredient as the new drugs during the administrative exclusivity
period can be continued only if there are ongoing clinical studies
on those drugs in question. Under the Draft Amendment, the
follow-on submissions will continue to be reviewed by the CFDA as
long as their IND applications are filed before the start of the
administrative exclusivity period.
2. Highlights of the Draft Contract Manufacturing Rules
The authority to review and approve contract
manufacturing will be delegated by the CFDA to its provincial
counterparts ("PFDAs"). In principle, the PFDA
where the outsourcing manufacturer is located will be responsible
for the review and approval of contract manufacturing. In the event
that the outsourcing manufacturer and the contract manufacturer are
located in different provinces, a pre-approval from the PFDA where
the contract manufacturer is located is also needed.
The CFDA will prohibit more categories of drugs from
contract manufacturing. In addition to vaccines and blood
products, narcotic drugs, psychotropic drugs, pharmaceutical
precursor chemicals and their drug preparations, biological
products, biochemical multi-component drugs, TCM injections, and
drug substances will also be prohibited from contract
On-site inspection by the PFDA will be
mandatory. In addition to paper-based review, the
appropriate PFDA will conduct on-site inspection to examine the
contract manufacturer's manufacturing conditions, technology
level, quality management, and the consistency of product standards
with those of the outsourcing manufacturer.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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