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Donfucius Says: March 29th, 2014. Random Bits Of Wisdom.

  1. “As a child my family’s menu consisted of two choices: take it or leave it!” — Buddy Hackett
  2. “Nature gave men two ends – one to sit on and one to think with. Ever since then man’s success or failure has been dependent on the one he used most.”Donfucius
  3. Preach the Gospel at all times, and when necessary use words.” — Aaron Rogers Quoting Francis of Assisi
  4. “Diplomacy is the art of saying “Nice doggie” until you find a rock.” — Will Rogers
  5. “Before they invented drawing boards, what did they go back to?” –Patti Molloy
  6. “The way we’re going… if I called up another pitcher, he’d just hang up the phone on me.” — Any Brewers Manager
  7. “When someone is impatient and says I haven’t got all day,” I always wonder, “How can that be? How can you not have all day?” — George Carlin
  8. “We’re fools whether we dance or not, so we might as well dance.” — Old & Wise Japanese Proverb
  9. “Blessed are the cracked – for they are the ones who let in the light.” — Donfucius
  10. “Good judgment comes from experience, and a lot of that comes from bad judgment.” — Will Rogers
  11. “I don’t mind how much my Ministers talk, so long as they do what I say.” — Margaret Thatcher

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ATL's Quality Corner

Archive for April, 2009



Digest Break. He Said It, Not Me…

April 28th, 2009

Will Rogers. 1879 – 1935.

“I never met a man I didn’t like.”

“I don’t make jokes. I just watch the government and report the facts.” — Will Rogers

The ATL Question Man #3: Japanese Pharmaceutical & Medical Device Labeling Requirements.

April 13th, 2009

Question. “I am a Regulatory Affairs Specialist for a company in Massachusetts. We provide regulatory, quality, and clinical services to the biomedical industry.

We understand that all labeling and instructions for use for medical devices in Japan are required to be written in the Japanese language.

We are now trying to understand exactly what the other labeling requirements are. With 5 levels of legislation in Japan ranging from the PAL to Ministry Ordinances to administrative notices released by the MHLW, it seems impossible to find the exact piece of legislation that details these requirements. Would you be able to help me find it?

Answer. I can understand your frustration. This is kind of like the FBI, CIA, ATF, and other U.S. government agencies not working together before 9-11. I will try to help you as best I can.
The Japanese House of Representatives passed and enacted the revised Pharmaceutical Affairs Law (PAL). The original PAL dates back to 1943, with subsequent revisions in 1948, 1960, and 1979. However, the basic purpose of the law has remained the same: to ensure the safety, efficacy, and quality of medical products in Japan.

The latest revisions to the PAL are meant to address the enhancements in the development and safety of new medical products in the 21st century. According to the Ministry of Health, Labor and Welfare (MHLW), the revised PAL is intended to strengthen the safety measures related to medical devices, enhance government regulations with respect to the application of biotechnology and genome technology in developing medical products, and fortify post marketing safety measures (and the review system for approval and license) while taking international conformity into account.
The revised PAL is a done deal, but MHLW has yet to finalize many of the regulation-level details. Thus, many of the proposed changes are currently in high-level “Parliamentary Act” form. The ministry will announce regulation-level details gradually over the next several years through what they call enabling notifications.

Photo Below: Label requirements can be confusing.

Reorganization of Authoritative Bodies in the MHLW
In addition to the Japanese PAL revisions, the MHLW is also reorganizing the structure of the authoritative bodies in the ministry as part of the government’s reform efforts. The MHLW signed a bill establishing an independent administrative institution that will merge the Organization for Pharmaceutical Safety and Research (OPSR, also known as Kiko), the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) — which is under the auspices of the National Institute of Health Sciences — and the Japan Association for the Advancement of Medical Equipment (JAAME).

Prior to their unification, OPSR/Kiko and the PMDEC operated as separate government entities. OPSR/Kiko was responsible for reviewing safety and efficacy of pharmaceuticals, and the PMDEC had similar responsibilities for medical devices. JAAME was an independent association working in conjunction with MHLW, focusing on “me-too,” or derivative medical devices.

The new institution is referred to as the Comprehensive Organization for Medicines and Medical Equipments. Its primary mission will be to ensure the quality, safety, and efficacy of medicines and medical equipment in Japan. The organization will also be responsible for improving national health by addressing health problems caused by adverse drug reactions (ADRs) and infections from biological products and promoting development in pharmaceutical technology through product reviews and fundamental research.

As for the changes in MHLW for labeling:
New Guidelines for Medical Devices Packaging

The MHLW has issued new guidelines for medical device packaging — The Guideline of Package Insert for Medical Devices — which aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent potential adverse events. Companies with already approved device products must revise their product inserts to comply with the new regulations. Basic package inserts should be in compliance with the information provided on the shonin (approval) application and should include the following:

Date of publication and most recent revision; Shonin number; Classification and generic name; Trade name; Warnings; Contraindications; Shape and structure; Performance indication for use, efficacy and/or effectiveness; Instructions for use and/or handling; Cautions; Principle of operation; Clinical records; Method and duration of preservation; Handling instructions; Maintenance instructions; Condition for shonin; Packaging information; Major reference papers and where they might be obtained; and Name and address of manufacturer and/or importer.

The name of the medical device, manufacturer’s serial number or lot number, and manufacturing code will be required to be affixed to the device or its immediate packaging. This is in addition to the direct presentation of the name of the distributor and expiration date on the medical equipment that is currently required.

If this is not the information you were looking for, I suggest you contact the “Japan Pharmaceutical Manufacturers Association” (JPMA).

Notable & Quotable: “A word to the wise ain’t necessary – it’s the stupid ones that need the advice.” — Bill Cosby

Digest Break. He Said It, Not Me…

April 7th, 2009

Niels Bohr, Danish Physicist, 1885-1962.

“Prediction is very difficult, especially about the future.”

The ATL “Question Man” #2: Security For Hospital Pharmaceuticals.

April 5th, 2009

Question. Do I need to employ security technologies for hospital-bound pharmaceuticals? Who would verify them?
Answer. The answer is must you or should you? Currently there is not a standardization for covert features as they pertain to security packaging.

You must employ security technologies if this is part of your contract with the buyer of your product. You must maintain the pedigree. If you are the brand owner, I feel strongly that you can protect the public by maintaining a record containing information regarding each transaction that results in a change of ownership of a given drug or pharmaceutical ingredient. This includes its sale by the manufacturer, through the wholesalers, distributors, and pharmacies. Overt and covert technologies work in tandem to track and trace and authenticate.

This includes: Lot or batch codes; Integrated Mass Serialization; 2D DataMatrix Codes; Forensic (invisible, non-degradable, nano-molecular) markers; and many other covert techniques.

Many people feel that President Obama will expect manufacturers to take immediate action to protect the drug supply chain, or else face regulation. This prediction comes from two members of the Partnership for Safe Medicine’s board of directors, Marvin D. Shepherd, Ph.D., and Bryan A. Liang, M.D., Ph.D., Partnership for Safe Medicines.

The Partnership for Safe Medicines is a coalition of more than 50 organizations and individuals dedicated to protecting consumers from counterfeit medicines.
“President Obama won’t have the patience that President Bush had waiting for industry,” explains Liang. The onus will be on industry, and the message will be, “If you don’t do it, we will make you do it.”
Shepherd believes that Obama will see to it that FDA mandates both serialization and authentication. “A layered approach will be favored, and companies will get to choose what technologies are employed. But the number of layers to be used may be dictated.”

Photo Below: Be careful when purchasing medications on-line. You may not be getting what you’re paying for.

Notable & Quotable: “Diplomacy is the art of saying “Nice doggie” until you can find a rock.” — Will Rogers

ATL’s Modern Day Parable. A Lesson Of Arrogance & Ignorance.

April 2nd, 2009

A spoiled, self-indulgent college freshman was walking along the beach. He took it upon himself to berate a senior citizen (who was resting on some steps) as to why it was impossible for the older generation to understand his generation.

“You grew up in a different world, actually, almost a primitive one”, the freshman said.

The young man continued his verbal abuse, and got louder and louder. His intent was to embarrass the older fellow in front of others on the beach. “The young people of today grew up with television, jet planes, space travel, and men walking on the moon. We have nuclear energy, ships and cell phones, computers with lightning speed, and so much more.”

After a brief silence, the senior citizen said to the impudent freshman, “You’re right, son. We didn’t have those things when we were young. So we invented them. Now, you arrogant little jerk, what are you going to do for the next generation?”

The applause from others on the beach was amazing.