Published: 16 March 2020

Publications

Q&A on generic medicines

6 March 2020

As a result of an interview and podcast on RNZ (Katherine Eban: Fraud in the generic drug industry), Medsafe has received several questions from healthcare professionals, consumers and the media regarding generic medicines.

We have summarised these questions in the following statement. All of this information is already on our website but in different places. These questions and answers help bring this information together.

Like all medicines with consent to be supplied in New Zealand, generic medicines are subject to a rigorous regulatory scheme that is administered by Medsafe. Generic medicines must meet high standards with regards to their quality, equivalent to brand name (innovator) medicines. Medsafe’s approval process and post-market quality and safety monitoring ensures that New Zealand patients can be confident that the generic medicines they take are of good quality, and are safe and effective.

What is a generic medicine?
How does Medsafe ensure the quality of generic medicines supplied in New Zealand?
How does Medsafe ensure that generic medicines are manufactured properly?
How does Medsafe ensure that a generic medicine works (is effective)?
How does Medsafe ensure the integrity of the data it assesses?
How are generic medicines tested?
What is ‘dual-track’ production?
Why does Medsafe recommend prescribing by brand for some medicines?
How does Medsafe monitor manufacturing sites, and what does Medsafe do when a quality issue at a manufacturing site is discovered?

What is a generic medicine?

A generic medicine is a copy of the original brand name (or innovator) medicine. It must have the same active ingredient, present in the same form and quantity, and have the same or similar dosage form (eg, tablet, injection, eye drop) as the innovator. Generic medicines work in the same way and have the same safety profile as innovator medicines, but may use different non-active ingredients (excipients).

Allowing generic medicines in New Zealand ensures there are alternative suppliers of medicines.  This generates choice (particularly for funders) and options in case of medicine shortages.

How does Medsafe ensure the quality of generic medicines supplied in New Zealand?

If a company wishes to sell a medicine in New Zealand, they must make an application to Medsafe. For a generic medicine the company must provide information demonstrating that the quality of the medicine meets acceptable standards and functions as well as the respective innovator. The company ensures all the ingredients used meet the required standards for purity and concentration, and that appropriate tests are used to check this.

More information on the Medsafe approval process for medicines, including generics

How does Medsafe ensure that generic medicines are manufactured properly?

Manufacturers of medicines for New Zealand must meet the high standards of Good Manufacturing Practice (GMP) and be regularly inspected and certified by medicine regulators who use the same standards as Medsafe. Regulators verify that manufacturing and testing continues to be conducted according to GMP.

If a manufacturing site has not been certified, Medsafe will audit the site. Medsafe audits sites in other countries, such as India and Turkey.

More information on manufacture of medicines (PDF 1058 KB, 13 pages)

How does Medsafe ensure that a generic medicine works (is effective)?

Because the company making the innovator has already shown that the active ingredient works and is acceptably safe, generic medicines don’t need clinical trials. The manufacturer of the generic medicine performs a bioequivalence study to demonstrate that the active ingredient gets into the body the same way as the innovator medicine in most people who take it. The efficacy and safety of a bioequivalent generic is generally accepted to be the same as the innovator.

The criteria for bioequivalence are based on mathematical constructs that take into account normal day to day variation in the amount of active ingredient a person absorbs. In practice medicines with a difference in absorption of more than 5% fail bioequivalence testing

A very small percentage of people may experience clinically significant different levels of the active ingredient. This is expected, and for most medicines this can be managed with a change in dose.

All medicines in New Zealand are monitored for safety by Medsafe.

More information on bioequivalence

How does Medsafe ensure the integrity of the data it assesses?

All data relating to the quality of medicines must be scientifically produced by manufacturing and testing sites that hold valid certification from Medsafe or Medsafe-recognised international regulatory authorities showing that they comply with Good Manufacturing Practice (GMP). All clinical studies including bioequivalence studies must be run according to Good Clinical Practice (GCP) and have ethics approval.

Medsafe works closely with other medicines regulators to identify and discuss data quality issues.

How are generic medicines tested?

Manufacturers of medicines must conduct validated tests at various steps of the manufacturing process, to ensure the quality meets acceptable standards. Manufacturing and testing steps are assessed and approved by Medsafe as part of the medicine approval process.

In addition, Medsafe has a medicine testing program for medicines on the market in New Zealand. Medicines are selected for routine testing to cover a range of products, dose forms, manufacturers and sponsors. This service is contracted to ESR, a Crown Research Institute.

What is ‘dual-track’ production?

Dual-track production refers to the practice of manufacturers supplying medicines that meet a lower quality standard to less regulated markets. Medsafe has no evidence of this occurring in New Zealand. Our regulatory system is designed to prevent this happening.

Why does Medsafe recommend prescribing by brand for some medicines?

Some medicines have a narrow therapeutic window and some anti-epileptic medicines should be prescribed by brand. This is because the few patients who experience a clinically significant difference in the amount of active ingredient reaching the blood, as mentioned above, can experience serious clinical consequences.

More information on prescribing by brand

How does Medsafe monitor manufacturing sites, and what does Medsafe do when a quality issue at a manufacturing site is discovered?

The standards for manufacturing medicines are high, and manufacturing sites are inspected regularly. Regulators expect that manufacturing sites continually improve their processes and the high standards for medicine manufacturers are continually increasing. This means that it is common for regulators to identify potential issues following an inspection (the FDA for example may issue several warning letters a week). Inspection findings can range from minor improvements through to more serious issues that need to be addressed immediately.

Medsafe receives formal notifications from other regulators, and suppliers of medicines in New Zealand, about inspection findings. We investigate these potential issues and when necessary require that a medicine is recalled.

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