LSHC Horizons Brochure 2024 - Flipbook - Page 65
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | APAC
Drug and medical device advertising in China
Multinational life sciences companies
considering commercializing products in
China should familiarize themselves with the
key rules governing the marketing activities of
drugs and medical devices.
As a starting point, China requires the contents
of advertisements for drugs or medical devices
to be reviewed by the relevant authorities
before publication. Specifically, any drug
advertisement must receive prior approval by
the competent provincial-level government
and can only be based on the package insert
pre-approved by the industry regulator, the
National Medical Products Administration
(NMPA). For medical devices, advertisers
must obtain an “approval serial number”
for the advertisement of a medical device.
Such “approval serial number” is issued only
after the contents of the advertisement have
been examined by the local NMPA, and any
subsequent alteration of the content will
require reapplication for approval.
Given the lack of a comprehensive law coupled
with rapid shifts in advertising channels and
formats, it is challenging to keep track of all
the regulatory requirements applicable to
the advertising of drugs or medical devices
in China. We have summarized the key
requirements here.
Andrew McGinty
Partner
Hong Kong
Additionally, pharmaceutical companies
operating in China usually engage in “academic
promotion,” which is a type of institutionto-institution, quasi-advertising activity that
involves the exchange of scientific information.
There are special rules governing the conduct
of academic promotion. In general, academic
promotional activities can only be undertaken
by registered medical representatives who are
professionals acting on behalf of a marketing
authorization holder (MAH) by conveying,
communicating, or collecting feedback
information about drugs. It is important to note
that academic promotion is not a sales activity.
Therefore, medical representatives cannot
perform drug sales, such as collecting payments
or dealing with purchase/sales invoices.
China has ramped up the enforcement of
pharmaceutical and medical device advertising
regulations in the past few years and has
gradually increased the penalties imposed
on non-compliant advertisers, advertising
agents, and publishers. However, challenges
can bring opportunities. A well-rounded team
of internal and external marketing experts,
regulatory specialists, and legal advisors
can help formulate promotional strategies
that maximize the products’ brand exposure
while ensuring compliance with the evolving
regulatory requirements.
Wensheng Ren
Counsel
Hogan Lovells Fidelity
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