The National Health Insurance Civilian Surveillance Alliance yesterday questioned the legitimacy of a certification for pharmaceutical manufacturers after a majority of the manufacturers that were required by the Food and Drug Administration (FDA) to re-file bioequivalence testing (BE) reports for changes made to their products were awarded PIC/S GMP or GMP certification.
BE testing is conducted to ensure that a generic drug delivers the same therapeutic effect as a reference brand-name pharmaceutical.
In response, the agency said that the changes to the drugs were “legitimate” and have no negative impact on drug safety.
At the end of August, the health insurance watchdog held a press conference to report that as many as 3,841 drug products failed to comply with pharmaceutical regulations after making changes to package inserts, packaging and the excipients used in drugs without seeking re-approval by the regulator.
In response, the agency promised to hold risk assessment meetings to evaluate the drugs that had been altered.
This month, the agency announced that 33 out of 3,841 generic drug products would need to be tested for their bioequivalence with brand-name medicines, with 21 more to be examined.
The group found that 10 of the 11 drug manufacturers that produce the 33 drugs are PIC/S GMP (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, or the guide to Good Manufacturing Practice for medicinal products) or GMP certified.
“The government has required all pharmaceutical manufacturers to be PIC/S-certified by the end of next year, after which those without will not be permitted to make or sell drugs in Taiwan,” alliance spokeswoman Eva Teng (滕西華) said.
“However, the 10 manufacturers account for 15.8 percent of the 57 PIC/S GMP-certified manufacturers in the country. This makes us concerned that the certification does not guarantee drug quality,” Teng added.
The lack of BE testing reports for drugs that have been altered is a major problem, the group said.
“Changing the excipient, the diluent or the vehicle of a drug could decrease its therapeutic effect,” alliance convener Huang Sue-ying (黃淑英) said, adding that the agency should have ordered that the 33 drug products be pulled off shelves immediately after the announcement this month.
“The agency asked doctors to look for substitutes as soon as possible, and said that the drugs were without health risks,” she said.
FDA official Chi Jo-feng (祁若鳳) said that the PIC/S GMP certificate would not be revoked unless the violations are “grave,” such as producing counterfeit drugs, adding that the drugs were not withdrawn from the market immediately because some patients need time to switch to a new drug.
The agency updated the list in a statement yesterday, announcing the final result of the assessment for the need of BE testing on a total of 54 drugs (including the 33 announced earlier), which said that only nine of the 54 would need to redo BE testing.
One of the 33 drugs required to be tested this month was made exempt because the manufacturer had subsequently handed in relevant documents, while several others decided to revert to the original formula or simply give up the permit for the drug and had their products pulled off shelves, an FDA official said.