Packaging and Labelling Drugs and Biologics in China

Packaging and Labelling Drugs and Biologics in China

Market Overview

The pharmaceutical industry in China has been constantly growing in recent years. As of 2018, the market was estimated at almost $153 billion, with prescription medicine accounting for 86% of total drug expenditure. In fact, it is estimated that it will reach over $160 billion by 2023 – accounting for some 30% share of the global market.

Due to low purchasing power and a robust local manufacturing sector, generic drugs ($85.3 billion) seized a large share of China’s pharmaceutical market ($219.9 billion). Sales of over the counter (OTC) medicines ($18.4 billion), which represent 13.6% of the market are supported by a cultural acceptance of self-medication and liberal sales channels. Patented medicines ($30 billion), which are primarily consumed by China’s affluent class, contributed a small portion (22.9%) to overall pharmaceutical sales.

Although China has expanded to be the second largest pharmaceutical market worldwide, growth has slowed from a 19% CAGR in 2008–2013 to an 8% CAGR in 2013–2018. On top of this, the market is expected to continue to decline to 3-6% through 2023. Much of China’s growth over the past ten years has been driven by central government reforms to expand insurance access to both rural and urban residents, to expand and modernize the hospital system, and reforms to better integrate primary care services. Growth moving forward will be attributed to the improvement of treatment concepts, the optimization of medical measures, the acceleration of new drug access, the improvement of medical service quality, and the dynamic adjustment of medical insurance access.

General Information

The insert sheet, labelling and packaging material information requirements for drugs are regulated under SFDA Decree No.24: Provisions for Drug Insert Sheets and Labels1. This provision, which was adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006 contains six ‘chapters’:

  • Chapter I – General Provisions
  • Chapter II – Drug Insert Sheet
  • Chapter III – Drug Labels
  • Chapter IV – Use of Drug Name and Registered Trademark
  • Chapter V – Other Provisions
  • Chapter VI – Supplementary Provisions

Drug Insert Sheet

 A drug insert sheet shall include the significant scientific data, conclusions and information concerning drug safety and efficacy to direct the safe and rational use of drugs. The specific format, content and writing requirements of drug insert sheet shall be prescribed and issued by the National Medical Product Administration (NMPA).

Disease names, pharmaceutical terms, drug names, the names, and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards.

All the active ingredients or medicinal ingredients of traditional Chinese medicines in a prescription shall be listed in the insert sheet. For injections and non-prescription drugs, all excipients shall be listed as well.

The ingredients or excipients included in a prescription, which may cause severe adverse reaction, shall be specified.

A drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely.

The NMPA may also require a drug manufacturer to make modification to the insert sheet based on the results of adverse drug reaction monitoring and drug re-evaluation.

After the modification to the insert sheet is approved, the drug manufacturer shall inform relevant drug distributors, drug users and other departments of the modified content immediately and use the modified insert sheet and label timely as required.

The insert sheet shall provide full information on adverse drug reaction and indicate the adverse reactions in detail. A drug manufacturer, who fails to timely modify the insert sheet based on the safety and efficacy data of the marketed drug or to fully explain the adverse reaction in the insert sheet, shall be liable for all the consequences arising therefrom.

The approval date and the modification date shall be distinctively shown in the insert sheet.

Chemical drugs and therapeutic biologics

The drug insert sheet of chemical drugs and therapeutic biologics shall follow the format:

  • The date of approval and revision by NMPA (placed on upper left corner of insert)
  • Symbol for narcotics, radiopharmaceuticals, toxic drugs and psychotropic drugs and drugs for external use (placed on upper right corner of insert)
  • Title of insert sheet: “xxxxx drug” with a note: “Please carefully read this leaflet and use under advice of doctors”.
  • Warnings
  • Drug name (generic name, trade name, English name)
  • Active pharmaceutical ingredient (chemical structure and chemical name, molecular structure, and weight)
  • Appearance
  • Indications
  • Packaging specification
  • Administration route and dose
  • Adverse reactions
  • Contraindications
  • Precautions
  • Pregnancy and lactation
  • Paediatric use
  • Elderly use
  • Drug interactions
  • Over dosage
  • Clinical trial data
  • Pharmacology and toxicology
  • Pharmacokinetics
  • Storage
  • Package
  • Expiry date/shelf-life
  • No. of Quality specifications
  • Approval no.
  • Manufacturer (name, tel., fax, postal code, website)

NMPA particularly requires that the proportion of generic and trade name of drug on labelling should at least be 1:2.

Over The Counter (OTC) chemical drugs

The drug insert sheet of OTC chemical drugs shall follow the format:

  • Symbol for OTC
  • Title of insert sheet: “xxxxx drug” with a note: “Please carefully read this leaflet and use under advice of pharmacists”.
  • Warnings
  • Drug name (generic name, trade name, English name)
  • Active pharmaceutical ingredient (chemical structure and chemical name, molecular structure, and weight)
  • Appearance
  • Indications
  • Packaging specification
  • Administration route and dose
  • Adverse reactions
  • Contraindications
  • Precautions
  • Drug interactions
  • Storage
  • Package
  • Expiry date/shelf-life
  • No. of Quality specifications
  • Approval no.
  • Date of modification versions
  • Manufacturer (name, tel., fax, postal code, website)

Biologics for prevention

The drug insert sheet of biologics for prevention shall follow the format:

  • The date of approval and revision by CFDA (placed on upper left corner of insert)
  • Title: “xxxx drug insert sheet”
  • Warning
  • Drug name
  • Active ingredient and appearance
  • Vaccinated population
  • Functions
  • Strength
  • Vaccination procedure and posology
  • Adverse reactions
  • Contraindications
  • Precaution
  • Storage
  • Package
  • Shelf-life
  • No. of Quality Standards
  • Approval no.
  • Manufacturer

Radiopharmaceuticals

The drug insert sheet of radiopharmaceuticals shall follow the format:

  • The date of approval and revision by NMPA (placed on upper left corner of insert)
  • Symbol for radiopharmaceuticals (placed on upper right corner of insert)
  • Title: “xxxx drug insert sheet”
  • Drug name
  • Active pharmaceutical ingredient
  • Appearance
  • Half time for radioactive nuclear element, (T1/2)
  • Radioactivity and marking time MBq (mCi)
  • Indications
  • Administration route and dose
  • Absorbed dosage.
  • Adverse reactions
  • Contraindications
  • Precautions
  • Pregnancy and lactation
  • Paediatric use
  • Clinical trial data
  • Pharmacology and toxicology
  • Pharmacokinetics
  • Storage
  • Package
  • Expiry date/shelf-life
  • Quality Standards
  • Approval no.
  • Manufacturer (name, tel., fax, postal code, website)

Labels

Drug labels refer to the information printed or pasted on drug packaging, including inner labels and outer labels. Inner labels refer to those that appear on immediate packaging; outer labels are those on the other packaging outside of inner labels.

The inner label shall bear such drug information as the adopted name in China, indications or functions, strength, dose and usage, production date, batch number, expiry date and manufacturer. If there is not enough space in the package to include all the information mentioned above, the adopted name in China, strength, batch number and expiry date shall be indicated at least.

The outer label of a drug shall indicate such information as the adopted name in China, ingredients, description, indications or functions, strength, dose and usage, adverse reactions, contraindications, precautions, storage, production date, batch number, expiry date, approval number and manufacturer. Where indications or functions, dose and usage, adverse reactions, contraindications, and precautions cannot be fully noted, main information plus a “See drug insert sheet for details.” notice shall be indicated.

The label on the package for transportation and storage shall bear at least the adopted name in China, strength, storage, production date, batch number, expiry date, approval number and manufacturer. Other information such as packaging quantity, precautions for transportation or other marks may be included when necessary.

The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied specifications, approval number and manufacturer. Other necessary information such as packaging quantity and precautions for transportation shall also be indicated.

Where one drug produced by a manufacturer has the same drug strength and packaging specification, the content, format, and colour of its labels must be the same. Where one drug produced by a manufacturer has different drug strengths or packaging specifications, its labels shall be clearly distinguished from one another, or its specifications shall be notably marked in the corresponding specification items.

Where a drug produced by a manufacturer is administrated as prescription drug and non-prescription drug respectively, their packaging colours shall be distinctly different.

For drugs with special requirements on storage, its requirements shall be marked in the notable place of the label.

The expiry date in the drug label shall appear in the order of year, month, and day, with year shown in four digits, month, and day in two digits. Its specific format shall be “Valid till XXXX year XX month” or “Valid till XXXX year XX month XX day”. It may be presented with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till XXXX/XX/XX”.

For the preventive biological product, the expiry date shall be labelled according to the registration specifications approved by the NMPA. The expiry date of the biological product for therapeutic use shall be counted from the filling date. For other drugs, the expiry date shall be counted from the production date.

Where the expiry date is labelled to the day, it shall be marked as one day earlier than the actual expiry date; where the expiry date is labelled to the month, it shall be marked as one month earlier than the actual expiry month.

Braille Text, Special Warning Requirements, Legal Status

  • No regulations for braille text are available.
  • Special warnings can be added on the drug insert sheet and labels by the manufacturer or demanded by the NMPA.
  • Trademarks that are not registered or other drug names that are not permitted by the NMPA, are not allowed to use on the drug insert sheet and labels.

Identification and Authenticity

All drugs must be labelled with the approval No. (License No.) assigned by the NMPA, preceded by the words “License No.” or “Guo Yao Zhun Zi”.

Symbols or Pictograms

Symbols are required under the following circumstances:

National Drug Code

National Drug Code was provided by Alibaba Healthcare in 2015. The China’s State Food and Drug Administration (CFDA) issued an announcement in 2015 to force the use of the national drug code but made another announcement in 2016 to stop the implementation of national drug code. On January 20th, 2017, the website for national drug code announced to stop the future update.

Bar Code Requirements

The bar code shall follow the requirement of Provisions of Goods Bar Code. For imported drug, the bar code in the home country can be used.

Multinational Packaging Possible

As the packaging and label shall be in Chinese, it is very hard to introduce a multinational packaging in China.

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